Podcasts about enhertu

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of remarkable updates that highlight the dynamic evolution of drug development, regulatory landscapes, and industry strategies. Takeda has made waves with its TYK2 inhibitor, Zasocitinib, which recently outperformed Bristol Myers Squibb's Sotyktu in a pivotal Phase 3 trial for plaque psoriasis. This trial is particularly noteworthy as it involves TYK2 inhibitors, a class of drugs targeting tyrosine kinase 2 to modulate immune responses. The success of Zasocitinib not only strengthens Takeda's competitive position but also underscores the potential of these inhibitors in treating autoimmune conditions like psoriasis. As we look forward to its market launch next year, this development represents a significant stride in the realm of targeted therapies aimed at complex diseases. Shifting gears to regulatory advancements, Johnson & Johnson's Darzalex (daratumumab) has received endorsement from NICE for its quadruplet therapy in newly diagnosed transplant-ineligible multiple myeloma cases. This approval is based on favorable Phase 3 trial results and highlights the therapeutic potential of targeting CD38 on myeloma cells. This marks a crucial step in offering potent treatment options to patients who cannot undergo transplants, emphasizing the growing importance of combination therapies in oncology. In another significant development, Johnson & Johnson is expanding its rare disease portfolio with promising Phase 2/3 trial data for Imaavy. Poised to become the first approved treatment for warm autoimmune hemolytic anemia, this advancement highlights the industry's pivot towards addressing rare diseases with limited treatment options. In India, AstraZeneca has secured CDSCO approval for Enhertu (trastuzumab deruxtecan) combined with pertuzumab as a first-line treatment for HER2-positive unresectable or metastatic breast cancer. This approval signifies a milestone in HER2-targeted therapies, spotlighting the pivotal role of antibody-drug conjugates that deliver cytotoxic agents directly to cancer cells, enhancing efficacy while minimizing systemic exposure. Moving on to business developments, Servier's partnership with N-Lorem Foundation to develop antisense oligonucleotide therapies for rare neurological disorders reflects the industry's increasing focus on precision medicine. This collaboration underscores the burgeoning interest in nucleic acid-based therapies aimed at addressing genetic disorders lacking effective treatments. On the financial front, Kardigan's planned $320 million IPO signals robust confidence in advancing cardiovascular pipeline assets. This move highlights Kardigan's commitment to tackling substantial unmet needs in cardiovascular diseases—an area still rife with challenges despite existing therapies. From a regulatory perspective, China's update of its Good Clinical Practice guidelines aims to streamline clinical trial processes, fostering biotech innovation. This change is expected to enhance drug development efficiency and attract global biotech investments to China's rapidly growing pharmaceutical market. Meanwhile, Pfizer CEO Albert Bourla has raised concerns about Germany's healthcare reform plans, warning that they might deter future investments. His comments underscore the delicate balance between cost containment policies and maintaining an environment conducive to pharmaceutical innovation. Additionally, Novo Nordisk's CEO Mike Doustdar expressed optimism about the company's strategic focus on market positioning through innovation and efficiency improvements. This aligns with broader industry trends where large pharma companies strive to maintain leadership roles amid fierce competition. Eli Lilly's sponsorship of short films premiered at Tribeca Festival illustrates an industry-wide trend toward patient-centric approaches and authentic portrayals of people with diseases onscreen. Such efforts aim to enhance communication strategies that resonate with diverse audiences. Furthermore, transformative technologies like cell and gene therapies are gradually moving towards mainstream clinical adoption. This transition necessitates zero-tolerance logistics to ensure these complex therapies reach patients safely and effectively—a paradigm shift offering potential cures but also posing logistical challenges. Finally, industry events such as ASCO continue to spotlight cutting-edge research developments in oncology. Such conferences are pivotal in advancing treatment paradigms and fostering collaborations that drive innovation across the sector. These updates reflect a period marked by groundbreaking scientific advances and strategic initiatives poised to reshape patient care and global healthcare solutions. As companies navigate these complexities while addressing regulatory and economic challenges, maintaining a focus on innovation will be key in charting future growth trajectories within the pharmaceutical and biotech sectors.Support the show

In a recent interview with CancerNetwork®, Nicholas Hornstein, MD, PhD, an assistant professor at the Donald and Barbara Zucker School of Medicine of Hofstra University and Northwell Health, discussed emerging data and clinical shifts in the care of patients with gastrointestinal (GI) cancers ahead of the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.Advancements in Colorectal CancerHornstein highlighted the increasing integration of targeted therapies into the first-line setting for patients with colorectal cancer (CRC). For those with BRAF V600E-mutated metastatic disease, data from the phase 3 BREAKWATER trial (NCT04607421) support moving targeted therapy into the first line.1 He noted that initiating these therapies early is critical, as a significant percentage of patients may experience rapid clinical decline and lose the opportunity for second-line treatment if targeted options are delayed.In the HER2-positive space, clinicians currently utilize tucatinib (Tukysa)-based regimens or fam-trastuzumab deruxtecan-nxki (Enhertu). Hornstein also anticipated the arrival of bispecific antibodies, such as zanidatamab-hrii (Ziihera), which are expected to gain approval in upper GI cancers before moving into the CRC landscape.The Role of ctDNA and Pancreatic CancerRegarding localized disease, Hornstein discussed the potential for circulating tumor DNA (ctDNA) to guide adjuvant therapy for patients with stage II colon cancer. Data from trials like CIRCULATE (NCT05174169) are expected to further clarify how ctDNA can assist in the escalation or de-escalation of treatment.2 In pancreatic cancer, the phase 3 RASolute 302 trial (NCT06625320) investigating daraxonrasib is poised to change the standard of care for patients with second-line pancreatic cancer immediately upon an anticipated regulatory approval.3Barriers to Precision MedicineA primary unmet need that Hornstein identified was the low rate of biomarker testing; currently, only about half of patients with metastatic disease receive necessary sequencing or microsatellite instability testing. Hornstein emphasized that multidisciplinary cooperation and improved systems are essential to ensure all patients with targetable mutations receive appropriate care. Finally, he highlighted the development of large language model tools to assist clinicians with data ingestion and clinical trial matching.References1.        Kopetz S, Wasan HS, Yoshino T, et al. BREAKWATER: primary analysis of first-line (1L) encorafenib + cetuximab (EC) + FOLFIRI in BRAF V600E-mutant metastatic colorectal cancer (mCRC). J Clin Oncol. 2026;44(suppl 2):13. doi:10.1200/JCO.2026.44.2_suppl.132.        Dasari A, Yu G, Kopetz S, et al. NRG-GI008: colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA). J Clin Oncol. 2026;44(suppl 16):TPS3686. doi:10.1200/JCO.2026.44.16_suppl.TPS36863.        Wolpin B, Wainberg ZA, Hendifar A, et al. Daraxonrasib, a RAS(ON) multi-selective inhibitor vs chemotherapy in previously treated metastatic pancreatic adenocarcinoma (mPDAC): Primary and final analysis from the phase 3 RASolute 302 study. J Clin Oncol. 2026;44(suppl 17):LBA5. doi:10.1200/JCO.2026.44.17_suppl.LBA5

From Discovery to Delivery: Charting Progress in Gynecologic Oncology, hosted by Ursula A. Matulonis, MD, brings expert insights into the most recent breakthroughs, evolving standards, and emerging therapies across gynecologic cancers. Dr Matulonis is chief of the Division of Gynecologic Oncology and the Brock-Wilson Family Chair at the Dana-Farber Cancer Institute, as well as a professor of medicine at Harvard Medical School, both in Boston, Massachusetts.In this episode, Dr Matulonis was joined by Meghan E. Shea, MD, an attending medical oncologist and ambulatory medical director and disease program leader for medical oncology at Beth Israel Deaconess Medical Center in Boston. Together, they explored the current landscape of cervical cancer, from the urgent need for expanded vaccination and screening to the evolving role of immunotherapy and antibody-drug conjugates (ADCs) across disease settings.Dr Shea opened by addressing the epidemiology of cervical cancer, noting that despite decades of progress, rates are now plateauing and rising among women under 50 years of age. She identified 3 interrelated drivers of this trend: declining rates of routine gynecologic screening, inconsistent uptake of human papillomavirus (HPV) vaccination, and persistent high-risk HPV infections, particularly HPV 16 and 18, which are responsible for most cases. The conversation then turned to the effect of immunotherapy on cervical cancer treatment. Dr Shea traced the evolution of pembrolizumab (Keytruda) from its initial 2018 approval as a single agent in recurrent/metastatic disease to its more recent integration into the frontline setting. The phase 3 KEYNOTE-A18 trial (NCT04221945) demonstrated that adding pembrolizumab to standard weekly cisplatin-based chemoradiation significantly improved outcomes for patients with locally advanced disease. Although responses to immunotherapy, when they occur, are often durable, Dr Shea acknowledged that response rates remain lower than anticipated for a virally driven malignancy, underscoring the need for novel combinations and a deeper understanding of resistance mechanisms. Drs Matulonis and Shea both agreed that immunotherapy combined with ADCs represents one of the most compelling directions for the field, with phase 2 data for sacituzumab tirumotecan plus pembrolizumab generating interest ahead of anticipated phase 3 results.On the ADC front, Dr Shea reviewed the 2 agents in this class that are currently FDA-approved for cervical cancer. Tisotumab vedotin-tftv (Tivdak) offers the advantage of biomarker-independent use, though its requirement for ophthalmologic monitoring at every treatment visit creates real-world access challenges outside major academic centers. Trastuzumab deruxtecan-nxki (Enhertu), approved in the HER2 immunohistochemistry 3+ setting based in part on the results of the phase 2 DESTINY-PanTumor02 trial (NCT04482309), has generated robust response rates but is most likely to benefit patients with adenocarcinoma. Dr Shea also highlighted additional targets under investigation, including Trop-2, Nectin-4, and B7-H4, with multiple phase 3 trials ongoing in both the frontline and recurrent settings.The discussion closed with a look at the locally advanced disease landscape, where the NRG Oncology cooperative group is conducting a phase 3 trial to evaluate whether integrating the neoadjuvant carboplatin/paclitaxel regimen from the INTERLACE trial (NCT01566240) with the pembrolizumab-based regimen from KEYNOTE-A18 can further improve outcomes and reduce the morbidity associated with brachytherapy. Dr Shea expressed optimism about this question, citing preliminary experience suggesting that neoadjuvant chemotherapy may reduce the need for invasive radiation techniques.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The industry is currently navigating a pivotal era marked by a blend of scientific innovation, regulatory shifts, and intriguing clinical trial results. A key regulatory upheaval unfolds as the FDA faces leadership changes. The recent departures of key figures from both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) underscore a period of uncertainty. With former commissioner Marty Makary stepping down, concerns arise about how these changes might affect drug approvals and regulatory guidance at such a crucial time in the industry. Turning to clinical trials, Regeneron has experienced a setback as its lag-3 inhibitor failed to surpass Merck's Keytruda in phase 3 melanoma studies. This marks Regeneron's second significant late-stage failure within a year, prompting analysts to reassess its strategic direction in oncology. In parallel, Regeneron has inked a $2.3 billion agreement with Parabilis Medicines to develop an advanced antibody-drug conjugate (ADC)-like therapy. The goal is to enhance targeting capabilities by improving binding to complex target sites, which could revolutionize ADC technology. Similarly, BioMarin's substantial investment in Inozyme's enzyme replacement therapy faced hurdles after falling short on one of two primary endpoints in a phase 3 trial for a rare genetic disorder. Such outcomes highlight the inherent risks and high stakes involved in late-stage drug development. Yet, innovation continues to drive progress. Vincentage Pharma's oral GLP-1 agonist has demonstrated a promising mean weight loss of 12.4% over a year, positioning it as a competitor to Eli Lilly's Orforglipron in the burgeoning Chinese market. This reflects the global pursuit to harness GLP-1 receptor agonists in tackling metabolic disorders and obesity. Ipsen has made strides with its long-acting neurotoxin for aesthetic applications, advancing into phase 3 trials following encouraging phase 2 results that showed significant improvements in frown lines lasting up to 24 weeks post-treatment. This progress suggests robust competition against established players like Botox. Meanwhile, Merck and Kelun-Biotech have successfully completed a phase 3 trial with their trop2-directed ADC sacituzumab tirumotecan (SAC-TMT) for endometrial cancer, achieving primary endpoints and paving the way for further regulatory submissions. Such advancements emphasize ADC technology's growing importance in oncology therapeutics. Broad industry trends reflect strategic investments, exemplified by Boston Scientific's $1.5 billion investment in Mirus and an option to acquire its transcatheter aortic valve replacement system—highlighting continued interest in high-growth medtech sectors. In another notable development, Daiichi Sankyo and AstraZeneca have reached a milestone with their ADC Enhertu, securing dual FDA approvals for early breast cancer treatment. These approvals underscore Enhertu's potential to expand treatment options for patients at an early disease stage, potentially altering standard treatment protocols. On the regulatory front, AstraZeneca has secured FDA approval for baxdrostat—an aldosterone synthase inhibitor developed through its acquisition of CinCor Pharma—demonstrating strategic investment in innovative cardiovascular therapies aligned with ambitious revenue goals. However, challenges persist as demonstrated by Amgen's Tavneos being linked to fatalities across Japan and the U.S., raising significant concerns about data integrity and pharmacovigilance. In contrast, Revolution Medicines' RAS inhibitor doubled survival rates in phase 3 pancreatic cancer trials. This breakthrough positions Revolution as an emerging leader in oncology therapeutics amidst fierce competition from companies aiming to improve drug tolerability and extend survival benefits. These narratives paint a picture of an industry poised for transformation—balancing scientific breakthroughs against regulatory challenges and financial pressures. As therapeutic modalities evolve—from oral biologics to advanced ADCs—the sector is set on course for substantial impacts on patient care and drug development pipelines. In summary, the pharmaceutical and biotech industries' focus on advancing therapeutic options through scientific innovation while navigating complex regulatory landscapes underscores an ongoing commitment to addressing unmet medical needs through new drug classes and targeted therapies. These efforts highlight trends toward personalized medicine and precision oncology that are likely to shape future trajectories in these dynamic fields.Support the show

Love the podcast? Send us a text!In this episode of Breast Cancer Conversations, host Laura Carfang speaks with Annick Pyfferoen about her experience being diagnosed with de novo metastatic breast cancer and navigating several lines of treatment including targeted therapy, chemotherapy, a clinical trial attempt involving tumor-infiltrating lymphocytes, Enhertu, and Xeloda. She speaks openly about what it felt like to experience rapid progression and why having a plan, even one that may change, helps her navigate uncertainty.This episode is a reminder that metastatic breast cancer care is not only about what is happening on scans. It is also about communication, side effect management, informed decision-making, emotional support, and helping people live as well as possible for as long as possible. Support the showListener FeedbackIf this episode resonated with you, we invite you to leave a review on Apple Podcasts or Spotify.You can also click the link in the show notes that says "Love this episode? Send us a text" to share feedback.Messages are completely anonymous.If you would like us to follow up directly, please include your email address in your message so we can respond.Latest News: Join our Mailing List - New content drops every Monday! Discover FREE programs, support groups, and resources from SurvivingBReastCancer.org! Become a Breast Cancer Conversations+ Member! Sign Up Now. Enjoying our content? Please consider supporting our work. 

Tomas Hansen, thoraxradiolog på Akademiska sjukhuset i Uppsala, lär oss allt som är värt att veta om Enhertu-inducerad pneumonit. Spoiler alert: Det är svårt, och kan se ut lite hur som helst! Blir du förvirrad av poddversionen kan det möjligen gå lättare att se avsnittet på Youtube, för då kan du ta del av bilderna från Tomas föreläsning. Vi går också igenom en zebra, i form av ett annat tillstånd som det är bra att känna till. Länk till Zebran: https://www.cmrad.com/cases/1037768488 Länk till intervjun med Tomas på Youtube: https://youtu.be/Jb8MZchx6_w Akutradiologikursens hemsida: www.akutradiologikursen.se Avsnittet presenteras i samarbete med Teleconsult. Läs mer om vad de kan erbjuda dig som radiolog, eller dig som chef på en underbemannad röntgenavdelning, på www.teleconsult.net !

Dr. Mayank Gandhi, CEO of NEOK Bio, discusses the company's work on bispecific antibody drug conjugates and the limitations of conventional ADCs, which target a single antigen. Using a bispecific antibody to target two unique antigens on a tumor can address the shortcomings of earlier approaches by improving delivery of the toxic payload, overcoming tumor heterogeneity, and reducing off-target toxicity.  NEOK has drugs in development for prostate cancer, and lung, head, neck, and gastrointestinal tumors. The trend for ADCs is toward multi-specific and multi-payload drugs, though Mayank warns it is not a simple task to go from one to many in designing these drug conjugates. Mayank explains, "There have been a lot of advancements in the last couple of decades, and especially the last few years, in various modalities in the treatment of hematological cancers, as well as to a certain degree in solid tumors. However, for many, many solid tumors, there's still a high unmet need given the still significant outcome, poor outcomes that patients experience, particularly with patients having metastatic disease across a variety of solid tumors. Now, if you look at specific modality like ADC or antibody drug conjugates, which is where NEOK Bio is, there's been a renaissance, if you will, with this modality in the last five to six years, particularly after the approval of a drug called Enhertu, which targets HER2 mutation. Now, many ADCs have been approved with different payloads. And so definitely that's made a dent in a variety of tumors, particularly in hematological cancers and select solid tumors as well."   "Conventional ADCs thus far target one antigen or one target on a tumor. So it's an antibody-based approach. The antibody is typically pursuing one specific antigen that's usually an antigen that's expressed on tumors selectively versus normal tissue or normal cells. And then you have a linker and a payload, usually a toxic payload that's conjugated via a linker to the antibody. So that's an antibody drug conjugate construct."   "Thus far, all the ADCs approved have been targeting only one antigen with a couple of different payloads. And so our bispecific approach is targeting two different antigens. If we use a bispecific antibody that targets two unique antigens on the tumor, we have more than one place that a potential antibody can bind and deliver the toxic payload. And then we have made some very significant improvements or changes in the antibody itself." #NEOKBio #DrugDevelopment #Innovation #AntibodyDrugConjugates #ADC #Oncology #Biotech#Oncology #SolidTumors #BispecificADC #CancerResearch #TranslationalResearch #MedicalOncology #HematologyOncology #ClinicalTrials #Biotech #Pharma #DrugDevelopment #PrecisionOncology #TumorMicroenvironment #TargetedTherapy NEOKBio.com Download the transcript here

Dr. Mayank Gandhi, CEO of NEOK Bio, discusses the company's work on bispecific antibody drug conjugates and the limitations of conventional ADCs, which target a single antigen. Using a bispecific antibody to target two unique antigens on a tumor can address the shortcomings of earlier approaches by improving delivery of the toxic payload, overcoming tumor heterogeneity, and reducing off-target toxicity.  NEOK has drugs in development for prostate cancer, and lung, head, neck, and gastrointestinal tumors. The trend for ADCs is toward multi-specific and multi-payload drugs, though Mayank warns it is not a simple task to go from one to many in designing these drug conjugates. Mayank explains, "There have been a lot of advancements in the last couple of decades, and especially the last few years, in various modalities in the treatment of hematological cancers, as well as to a certain degree in solid tumors. However, for many, many solid tumors, there's still a high unmet need given the still significant outcome, poor outcomes that patients experience, particularly with patients having metastatic disease across a variety of solid tumors. Now, if you look at specific modality like ADC or antibody drug conjugates, which is where NEOK Bio is, there's been a renaissance, if you will, with this modality in the last five to six years, particularly after the approval of a drug called Enhertu, which targets HER2 mutation. Now, many ADCs have been approved with different payloads. And so definitely that's made a dent in a variety of tumors, particularly in hematological cancers and select solid tumors as well."   "Conventional ADCs thus far target one antigen or one target on a tumor. So it's an antibody-based approach. The antibody is typically pursuing one specific antigen that's usually an antigen that's expressed on tumors selectively versus normal tissue or normal cells. And then you have a linker and a payload, usually a toxic payload that's conjugated via a linker to the antibody. So that's an antibody drug conjugate construct."   "Thus far, all the ADCs approved have been targeting only one antigen with a couple of different payloads. And so our bispecific approach is targeting two different antigens. If we use a bispecific antibody that targets two unique antigens on the tumor, we have more than one place that a potential antibody can bind and deliver the toxic payload. And then we have made some very significant improvements or changes in the antibody itself." #NEOKBio #DrugDevelopment #Innovation #AntibodyDrugConjugates #ADC #Oncology #Biotech#Oncology #SolidTumors #BispecificADC #CancerResearch #TranslationalResearch #MedicalOncology #HematologyOncology #ClinicalTrials #Biotech #Pharma #DrugDevelopment #PrecisionOncology #TumorMicroenvironment #TargetedTherapy NEOKBio.com Listen to the podcast here

Purpose of the episode: Ian Jessop interviews Slavka Geary, a UK-based stage 4 HER2-positive breast cancer patient now in remission, about her use of natural therapies and cannabis oil alongside partial conventional treatment. 00:37 Originally diagnosed at stage 2 in 2021, Slavka was restaged to stage 4 metastatic after a CT scan found cancer spread to her lungs within six months, with doctors giving her one year to live without chemotherapy. 02:55 Skepticism toward chemotherapy was shaped by witnessing relatives and friends decline rapidly after conventional treatment, leading Slavka to question whether treatment accelerated their deaths. 04:25 Initial natural therapies, including those recommended by a naturopathic doctor, were deemed insufficient against the fast-growing HER2-positive subtype; cannabis oil was not initially pursued due to UK legal stigma. 05:01 Introduction to cannabis oil came through a church acquaintance, Joshua, who was battling brain cancer; oil was sourced from Czech Republic, but reached Joshua too late—two weeks before his death. 06:14 After Joshua's passing, his wife offered Slavka the remaining oil; she began using it and found it effective, with her stage 4 lung metastases remaining stable and later reducing in size over two years without conventional treatment. 09:49 Cannabis oil is taken as a nightly maintenance dose of 4 drops (1:1 ratio), down from 8 drops during active treatment; earlier protocol also included daily suppositories, which aided sleep, relaxation, and pain relief post-surgery. 10:55 Slavka voluntarily stopped the palliative chemotherapy drug Enhertu (prescribed for life) after seven months, citing severe side effects including acute diarrhea, hospitalization, and feeling mentally and physically suppressed even at a reduced 60% dose. 13:16 Residual effects post-treatment include neuropathy in the left arm and hand, linked to lymph node removal and mastectomy; fatigue persists, though Slavka returned to work after stopping chemotherapy to regain quality of life. 17:09 Hyperbaric oxygen chamber sessions were used alongside cannabis oil during chemotherapy; the combination likely mitigated the severity of side effects, as Slavka appeared visibly unwell during sessions shortly after chemo doses. 18:48 Dietary changes included two years on a modified Gerson protocol—primarily vegan with weekly white fish or organic yogurt, daily fresh juicing, and one coffee enema per day; diet has since returned to a balanced, vegetable-rich normal diet. 24:02 Mind-body connection was identified as central to recovery; Slavka emphasized that fear-inducing prognoses from doctors can negatively impact healing by triggering a cycle of anxiety that affects physical health. 27:22 Cancer diagnosis fundamentally altered Slavka's worldview and emotional life; persistent background anxiety about recurrence and social isolation from non-cancer peers are ongoing psychological realities. 30:59 Most recent scan showed lung metastases have reduced in size compared to the prior scan, with no conventional treatment since September 2024—only nightly cannabis oil and natural remedies. 33:19 Slavka now informally supports one to two people per week affected by cancer, sharing her personal experience with natural remedies while being careful not to prescribe, focusing on emotional reassurance. 34:03 Visit our website: CannabisHealthRadio.comFind high-quality cannabis and CBD + get free consultations at MyFitLife.net/cannabishealthDiscover products and get expert advice from Swan ApothecaryFollow us on Facebook.Follow us on Instagram.Find us on Rumble.Keep your privacy! Buy NixT420 Odor Remover Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Breast Cancer Briefing, hosted by Sara Nunnery, MD, MSCI, a breast medical oncologist and the director of Breast Cancer Research at Tennessee Oncology in Nashville, is a podcast series that breaks down the latest news in breast cancer research, one conversation at a time.In today's episode, filmed live onsite at the 43rd Annual Miami Breast Cancer Conference, Dr Nunnery sat down with Kelly E. McCann, MD, PhD, a breast medical oncologist in the University of California system.Their conversation centered around the evolving HER2-positive breast cancer treatment paradigm. The experts highlighted that although this disease was once associated with a poor prognosis, targeted therapies like trastuzumab (Herceptin) have revolutionized management, making these cancers highly curable.They noted the role of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu), an antibody-drug conjugate (ADC) that delivers chemotherapy directly to cancer cells and uses a bystander effect to kill neighboring malignant cells. The phase 3 DESTINY-Breast11 trial (NCT05113251) evaluated T-DXd in the neoadjuvant setting for patients with high-risk, HER2-positive early breast cancer. Results showed significantly higher pathological complete response rates with T-DXd followed by docetaxel, trastuzumab, and pertuzumab (Perjeta) compared with standard chemotherapy. Responses were even more pronounced in patients with hormone receptor–negative disease.Furthermore, they spotlighted the phase 3 DESTINY-Breast05 trial (NCT04622319), which examined T-DXd as adjuvant therapy for high-risk patients with residual HER2-positive disease. In this study, T-DXd generated an improvement in invasive disease–free survival compared with standard ado-trastuzumab emtansine (Kadcyla). They noted that a significant benefit of T-DXd is its ability to cross the blood-brain barrier, offering the potential for preventing brain metastases. However, the experts expressed caution regarding interstitial lung disease, a potentially fatal adverse effect associated with T-DXd. Because of this risk, patients who receive T-DXd require frequent, expensive CT monitoring, which Nunnery and McCann explained can pose logistical and insurance challenges in standard practice.Although adjuvant T-DXd has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines for HER2-positive breast cancer, the neoadjuvant regimen has not yet been included, likely awaiting more mature survival data. Both oncologists conclude that although ADC-associated toxicities require vigilant management, these treatment advancements provide powerful new tools for potentially curing high-risk patients with HER2-positive breast cancer.

Drs. Isaacs and Traina discuss DESTINY-Breast09, where first‑line T‑DXd + pertuzumab clearly outperforms the CLEOPATRA regimen in progression-free survival for metastatic HER2+ breast cancer. They focus on the dilemma of when to use T‑DXd: earlier, for maximal efficacy, or later, to protect quality of life and manage ILD and cardiac risks.

Drs. Isaacs and Traina review how HER2CLIMB‑05 and PATINA challenge the old CLEOPATRA‑based approach by showing that adding tucatinib or palbociclib to maintenance therapy can extend progression‑free survival in metastatic HER2+ breast cancer. They stress tailoring maintenance regimens to each patient's hormone receptor status, CNS risk, and tolerance for side effects.

Drs. Isaacs and Traina discuss new data in HER2+ breast cancer from the 2025 San Antonio Breast Cancer Symposium, focusing on early-stage studies including DESTINY-Breast11 and DESTINY-Breast05 and how data from these studies could potentially impact patient care in the future.

From Discovery to Delivery: Charting Progress in Gynecologic Oncology, hosted by Ursula A. Matulonis, MD, brings expert insights into the most recent breakthroughs, evolving standards, and emerging therapies across gynecologic cancers. Dr Matulonis is chief of the Division of Gynecologic Oncology and the Brock-Wilcon Family Chair at the Dana-Farber Cancer Institute, as well as a professor of medicine at Harvard Medical School, both in Boston, Massachusetts.In this episode, Dr Matulonis sat down with guest Susana M. Campos, MD, MPH. Dr Campos is the clinical director and director of Educational Initiatives for the of the Division of Gynecologic Oncology at Dana-Farber Cancer Institute, and an institute physician and assistant professor of medicine at Harvard Medical School in Boston, Massachusetts. Drs Matulonis and Campos discussed the evolving landscape of newly diagnosed cervical cancer, from epidemiologic trends to emerging therapeutic strategies.According to 2026 estimates from the American Cancer Society, approximately 13,400 new cases of invasive cervical cancer will be diagnosed in the United States, with roughly 4200 deaths. Although incidence has declined over time due to human papillomavirus (HPV) vaccination and screening efforts, rates have plateaued, and the disease burden remains substantial, particularly among women aged 35 to 64 years. Dr Campos noted that approximately half of cases occur in women younger than 50 years of age, and about 20% are diagnosed in women older than 65 years of age.Dr Campos reviewed common presenting symptoms, including abnormal vaginal bleeding, intermenstrual or postmenopausal bleeding, abnormal discharge, pelvic pain, and, in advanced cases, urinary symptoms or leg swelling. She explained that diagnosis begins with pelvic examination and cervical cytology or HPV testing, followed by colposcopy and biopsy when indicated. Although cervical cancer remains one of the few malignancies that is clinically staged, imaging modalities, such as MRI, CT, and PET scans, are critical to accurately defining disease extent, they underscored. Moreover, the discussion highlighted transformative advances in locally advanced disease. The phase 3 KEYNOTE-A18 trial (NCT04221945) demonstrated improved progression-free and overall survival with the addition of pembrolizumab (Keytruda) to standard chemoradiation, establishing a new standard for high-risk patients, Campos stated. Similarly, the phase 3 INTERLACE trial (NCT01566240) showed that short-course induction chemotherapy with carboplatin and paclitaxel before chemoradiation improved long-term outcomes. Campos forecasted that ongoing studies, including the phase 3 NRG-GY037 trial (NCT07061977), may integrate these approaches and further refine optimal treatment sequencing.Lastly, Drs Matulonis and Campos highlighted the expanding therapeutic arsenal in the recurrent and metastatic setting. Campos noted how antibody-drug conjugates, such as tisotumab vedotin-tftv (Tivdak) and fam-trastuzumab deruxtecan-nxki (Enhertu), have demonstrated meaningful activity, particularly in biomarker-selected populations. Campos added that investigational strategies targeting TROP2, such as sacituzumab govitecan-hziy (Trodelvy), represent additional promising avenues.Despite these advances, both experts emphasized that prevention remains paramount. Widespread uptake of HPV vaccination, including the 9-valent vaccine, as well as adherence to routine cervical screening, are essential to reducing the long-term burden of this largely preventable disease.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we'll delve into the multitude of changes and advancements sweeping across the industry, each with profound implications for drug development, patient care, and market dynamics.The pharmaceutical landscape continues to transform as companies like Daiichi Sankyo make significant progress with antibody-drug conjugates (ADCs). Their collaboration with AstraZeneca on products like Enhertu and Datroway represents a robust push into earlier lines of therapy. This strategic move aligns with a broader industry trend where ADCs are being positioned as front-line oncology treatments. These therapies are lauded for their targeted delivery mechanisms that maximize therapeutic efficacy while minimizing off-target effects. However, the competitive landscape is becoming increasingly fierce, necessitating robust clinical data to stand out in this rapidly evolving market segment.Elsewhere, Moderna's recent decision to pause new late-stage trials for infectious disease vaccines highlights the intricate interplay between public sentiment and corporate strategy. The rising anti-vaccine sentiment in the U.S., compounded by diminishing support infrastructure from previous administrations, has significantly influenced Moderna's strategic recalibration. This situation underscores a critical challenge for developers of mRNA platforms: how to navigate complex public perceptions and policy landscapes while pushing forward with vaccine innovations.From a regulatory perspective, Recipharm's commissioning of a new facility in Bengaluru, India for non-bacterial beta-lactam drugs aligns with evolving FDA standards. This investment is not just about compliance; it's a proactive adaptation to meet rising customer demand and represents a strategic partnership with a major biopharmaceutical player. Such collaborations are crucial as they help scale drug production capabilities effectively.The dissolution of the marketing partnership between Arcutis and Kowa over Zoryve reflects the ever-dynamic nature of commercial collaborations within the industry. Originally intended to broaden Zoryve's market beyond dermatologists to include primary care physicians, this shift may indicate strategic realignments or divergent priorities between partners. Such changes can significantly impact market penetration strategies and highlight the importance of aligned goals within partnerships.In Europe, regulatory expansion by GSK of its Arexvy vaccine for all adults marks a pivotal milestone in widening access to crucial vaccines. This development not only enhances GSK's market presence but also underscores the agility required in regulatory responses to public health needs.On the financial front, settlements under the False Claims Act reaching $6.8 billion in FY2025 demonstrate heightened scrutiny on compliance practices within the industry. This serves as a stark reminder of both financial and reputational risks tied to non-compliance and underscores an ongoing need for stringent oversight mechanisms.Amidst economic uncertainties, AstraZeneca's decision to pause its UK research site investment reflects broader industry challenges related to strategic reallocations of resources. Companies are increasingly re-evaluating their geographic footprints and investment priorities in response to evolving market conditions.In precision oncology, Guardant Health's FDA approval for its Guardant360 CDx test in conjunction with Pfizer's Braftovi highlights how companion diagnostics are becoming integral in enhancing therapeutic outcomes through tailoring treatments based on specific genetic profiles. These developments illustrate a multifaceted landscape where scientific innovation, regulatory changes, strategic partnerships, and compliance considerations converge.The recent landscapSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. As we delve into the year 2025, it's clear that the pharmaceutical and biotech industries have been navigating a complex landscape filled with both challenges and remarkable advancements. Despite regulatory uncertainties and broader economic fluctuations, the FDA approved 55 new treatments and vaccines this year. Although this figure represents a slight decline from previous years, it underscores the sector's resilience and steadfast commitment to innovation even amid external pressures.One significant development in oncology comes from Incyte, which is advancing its application for FDA approval of a seven-drug Monjuvi regimen as a first-line treatment for diffuse large B-cell lymphoma. This move is backed by positive Phase 3 trial results, highlighting Monjuvi's potential to enhance treatment options for this aggressive cancer type. However, Incyte may face hurdles in gaining regulatory approval and achieving commercial success, reflecting the competitive nature of oncology therapeutics.In obesity management, Novo Nordisk introduced its once-daily Wegovy pill in the U.S., marking a milestone in the field. Priced at $149 per month for cash-paying patients with potential discounts for those insured, Wegovy's launch could shift market dynamics significantly by offering a more accessible treatment option. This aligns with the growing global focus on obesity as a critical public health issue.The industry also saw substantial investments to bolster manufacturing capabilities. Daiichi Sankyo announced plans to invest $1.9 billion to expand Enhertu production facilities across countries such as the United States, China, Japan, and Germany. This strategic move aims to strengthen supply chain robustness and meet anticipated demand for Enhertu, a pivotal player in cancer therapeutics. Meanwhile, economic pressures are palpable as drugmakers raised prices on over 350 products at the start of the year, surpassing previous years' increases. This reflects ongoing tensions around drug pricing policies and affordability, posing challenges for industry stakeholders and patients alike.The labor landscape within biopharma has been affected as well, with layoffs increasing by 16% year-over-year in 2025. These reductions highlight ongoing cost-cutting measures amid financial uncertainties and strategic realignments within companies. Yet, strategic partnerships continue to shape research and development efforts, particularly in autoimmune diseases. Sanofi's collaboration with AI biotech Earendil Labs could potentially reach $2.5 billion, emphasizing the increasing role of artificial intelligence in drug discovery and development processes. These collaborations are poised to accelerate advancements in personalized medicine and innovative therapeutic approaches.Regulatory activities have also seen notable developments this year. GSK's Nucala received approval for treating COPD in China, expanding its therapeutic scope beyond asthma. This regulatory progress signifies opportunities for existing drugs to access new markets and indications. However, the National Institutes of Health faced leadership challenges with the departure of its National Institute of Neurological Disorders and Stroke director. This adds to a series of leadership changes across NIH institutes, raising concerns about stability within this pivotal organization responsible for advancing medical research.Turning now to significant scientific advancements and clinical trials, promising results emerged from studies focused on cellular energy boosters aimed at treating Alzheimer's disease. A molecule that restores cellular energy was shown to reverse cognitive decline in mice with advanced Alzheimer's, suggesting a potential new class of therapeutics for this debilitating condition. Support the show

Drs. Yu and Herzberg discuss recent developments in HER2- and EGFR-targeted therapies for lung cancer, focusing on clinical trial results at ESMO 2025. Key highlights include promising response rates, toxicity profiles, and the potential for these targeted therapies to treat patients with specific genetic mutations, particularly those with CNS metastases.

Drs. Herzberg and Yu continue their discussion on emerging clinical data presented at ESMO and WCLC 2025. They highlight recent advancements in HER2-targeted therapies for NSCLC and review new HER2-targeted therapies, international study results, and the promise of evolving targeted approaches for HER2-altered lung cancer.

Drs. Herzberg and Yu explore emerging clinical data from the 2025 meetings of the European Society For Medical Oncology (ESMO) and World Conference on Lung Cancer (WCLC), highlighting recent advancements in HER2-targeted therapies for NSCLC. Their discussion focuses on new drugs (eg, zongertinib and trastuzumab deruxtecan), their efficacy and safety profiles, and the potential for treating HER2 mutations and overexpression.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In the ever-evolving landscape of pharmaceuticals and biotechnology, a series of strategic transactions and scientific advancements are reshaping the industry.BioMarin's acquisition of Amicus Therapeutics for $4.8 billion is a significant highlight, marking the company's largest transaction to date. This move signifies a strategic pivot towards enhancing its capabilities in the rare disease sector, leveraging Amicus's expertise and robust pipeline to potentially improve patient outcomes in this highly specialized area. This acquisition is expected to enrich BioMarin's portfolio significantly with promising assets from Amicus, reflecting a strategic shift under new leadership towards rare disease treatments.Regulatory affairs have seen considerable activity as well, with the FDA raising concerns over manufacturing practices at Catalent's gene therapy facility. These issues, documented in a Form 483 following inspections, particularly pertain to the production of Elevidys. Such regulatory scrutiny emphasizes the critical importance of maintaining compliance with manufacturing standards in gene therapy—a burgeoning field within biotech that holds immense promise for treating genetically-driven conditions.The FDA's oversight extends beyond manufacturing practices to advertising, as evidenced by an untitled letter issued to Bristol Myers Squibb regarding their Cobenfy TV ad. This action is part of the FDA's broader initiative to ensure that direct-to-consumer marketing materials accurately portray drug benefits and risks, thereby protecting public health.In another strategic move, Alvotech and Teva are gearing up for the 2026 U.S. launch of an Eylea biosimilar following a settlement with Regeneron. This development highlights the competitive dynamics within the biosimilar market—a segment poised for growth as patents on major biologics expire, offering more cost-effective alternatives and expanding treatment access.Meanwhile, Clovis Oncology has achieved a milestone with Rubraca, which transitioned from accelerated approval to full FDA endorsement for prostate cancer treatment after five years. This progression underscores Rubraca's demonstrated efficacy and safety profile in addressing advanced prostate cancer—a notable achievement amid an increasingly competitive oncology market.Policy changes proposed by Health and Human Services Secretary Robert F. Kennedy Jr. could have profound implications by disrupting funding streams for hospitals providing gender-affirming care to minors. The potential impact on healthcare providers and patients who rely on these services is significant.Turning to clinical trials, Daiichi Sankyo has seen success with Enhertu receiving FDA approval for first-line HER2-positive breast cancer treatment. Nonetheless, challenges persist as a separate phase 3 trial for another antibody-drug conjugate was paused due to unexpected patient deaths. Meanwhile, Takeda plans to seek FDA approval for its TYK2 inhibitor following successful phase 3 trials in psoriasis—indicating promising potential in autoimmune disease therapies.Strategic shifts are evident across organizations as well, highlighted by Kathy Fernando's departure from Pfizer to join Replicate Bioscience as Chief Business Officer. Her new role focuses on advancing Replicate's self-replicating RNA technology platform—an area gaining traction due to its implications for vaccine development and therapeutic applications.On the clinical trials front, Altimmune reported encouraging results from a 48-week study on metabolic dysfunction-associated steatohepatitis (MASH). Their GLP-1/glucagon dual receptor agonist demonstrated sustained weight loss and improvements in non-invasive liver fibrosis measures—offering new hope for MASH patients who face limited treSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant updates that are shaping the future of healthcare, patient care, and drug development.The U.S. Food and Drug Administration has been particularly active recently, granting Johnson & Johnson a National Priority Review Voucher for its multiple myeloma drug combination. This move highlights the importance of J&J's treatment in addressing unmet needs within oncology, a field continuously striving for innovative solutions. These vouchers expedite the review process, reflecting a broader commitment to accelerating the availability of critical therapies for patients who need them most.Continuing with regulatory advancements, AstraZeneca and Daiichi Sankyo's Enhertu, in combination with Roche's Perjeta, has gained FDA approval as a first-line treatment for unresectable or metastatic HER2-positive breast cancer. This breakthrough is supported by late-stage study results demonstrating a 44% reduction in disease progression or death compared to standard care. The approval signifies not only progress in breast cancer therapeutics but also underscores the potential benefits of strategic collaborations in drug development. Such partnerships are increasingly vital as they aim to optimize therapeutic efficacy through shared expertise and resources.In contrast to these advancements, Pfizer is facing financial recalibrations with projected revenues for 2026 estimated to decline due to diminishing COVID-19 vaccine sales and patent expirations. This situation reflects broader industry challenges as companies navigate post-pandemic market dynamics and patent cliffs, forcing reevaluations of long-term strategies.On another front, Gilead Sciences continues to push boundaries in HIV treatment with a promising single-tablet regimen combining bictegravir and lenacapavir. This innovation targets underserved segments within the HIV market, offering streamlined treatment options that could enhance patient adherence and outcomes significantly.Shifting focus to obesity management, Novo Nordisk's oral semaglutide is emerging as a highly anticipated medication among primary care providers. This trend highlights a growing preference for oral GLP-1 therapies as convenient alternatives to injectable formulations, marking a shift in how obesity—a major public health concern—is managed.The importance of regulatory compliance remains evident as Novo Nordisk received an FDA warning letter concerning manufacturing issues at an Indiana site previously owned by Catalent. This incident underscores the necessity for rigorous quality control in pharmaceutical manufacturing, which can have far-reaching implications on operational dynamics and supply chains.The FDA is also pioneering efforts to incorporate real-world evidence into medical device submissions by opening pathways for extensive deidentified datasets from sources like national cancer registries and electronic health records. This policy shift aims to integrate diverse data sources into the evidentiary foundation for medical device evaluations, potentially fostering innovation within this sector.In line with collaborative efforts, Genentech has partnered with Caris Life Sciences in a multi-year agreement valued at up to $1.1 billion, emphasizing the strategic importance of integrating diagnostic advancements with therapeutic developments to achieve precision medicine goals.Meanwhile, Yarrow Bioscience has acquired an autoimmune thyroid disease drug from China's Gensci, exemplifying a growing trend of cross-border collaborations aimed at leveraging global innovation ecosystems to address diverse therapeutic areas. This acquisition is part of a $1.37 billion deal, reinforcing the globalization of biotech partnerships as companies seek access to novel therapeutics andSupport the show

From Discovery to Delivery: Charting Progress in Gynecologic Oncology, hosted by Ursula A. Matulonis, MD, brings expert insights into the most recent breakthroughs, evolving standards, and emerging therapies across gynecologic cancers. Dr Matulonis is chief of the Division of Gynecologic Oncology and the Brock-Wilcon Family Chair at the Dana-Farber Cancer Institute and a professor of medicine at Harvard Medical School, both in Boston, Massachusetts. In this episode, Dr Matulonis sat down with guest Panagiotis (Panos) A. Konstantinopoulos, MD, PhD, to discuss the different subtypes of endometrial cancer and treatment developments for this disease. Dr Konstantinopoulos is the director of Translational Research in the Division of Gynecologic Oncology, the director of the Mellen and Eisenson Family Center for BRCA and Related Genes, and the Velma Eisenson Chair for Clinical and Translational Research at Dana-Farber Cancer Institute; as well as a professor of medicine at Harvard Medical School. Drs Matulonis and Konstantinopoulos explained that patients with mismatch repair–deficient (dMMR) tumors substantially benefit from a decreased risk of progression or death when immunotherapy is added to standard therapy. They noted that immunotherapy appears important for the management of dMMR tumors, even those in earlier stages or in patients who have no measurable disease remaining after surgery. For MMR-proficient (pMMR) tumors, Drs Matulonis and Konstantinopoulos highlighted that PD-1 blockade combined with chemotherapy improves survival vs chemotherapy alone, but that this benefit is not as substantial as that seen in dMMR disease. Crucially, they reported that if a pMMR tumor has no measurable disease after surgery, adding immune checkpoint blockade does not appear beneficial. They stated that tailored treatment approaches are key for managing pMMR disease subtypes. They added that hormonal therapy may be used upfront for slow-growing, estrogen receptor–positive metastatic disease. They continued by saying that DNA damage and replication stress are critical targets, particularly in p53-mutated tumors, like uterine serous cancers. Furthermore, they stressed that although the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (Enhertu) is highly effective in HER2-positive tumors, treatment with this agent requires monitoring for toxicities, including interstitial lung disease and decreased ejection fraction.

Daiichi Sankyo has been pioneering ADCs since 2010, with a pipeline targeting over 30 indications and potentially reaching 400,000 patients.In today's episode I'm joined by Dr. Markus Kosch, Head of the EU Oncology Business Division at Daiichi Sankyo. A physician by training with a deep academic background in oncology, Markus has spent over two decades advancing cancer care, from clinical practice to leadership roles shaping strategy across Europe and Canada. Since joining Daiichi Sankyo in 2021, he has been at the forefront of one of the industry's most ambitious ADC pipelines, overseeing more than 60 clinical trials across 24 countries and driving landmark approvals that are redefining treatment in breast, lung, and gastric cancers.This week's episode is brought to you with the support of Kadans. Looking for the perfect space to grow your Life Sciences company? Kadans Science Partner is Europe's leading provider of cutting-edge lab and offices spaces, tailored to your needs. Kadans puts you at the centre of innovation, giving you the chance to connect with top researchers, universities, and investors through its international network. Here, you'll join a vibrant community of innovators driving real change. Are you ready to take your research to the next level? Learn more at kadans.com – where innovation thrives. 01:45.         Meet Markus Kosch03:12.         Clinical background shaping an industry role04:46.         Daiichi Sankyo's 40-year oncology legacy06:19.         European investments and Munich hub10:34.         ADC platform strengths explained14:20.         Key ESMO 2025 trial dataClarification: The reference to ‘TB01' at 16:24 refers to the TROPION-Breast02 clinical trial, not TB01.19:43.         Managing risks and partnerships23:35.         Patient advocacy in trial design33:59.         Future of oncology and ADCsInterested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletterTo dive deeper into the topic: 10 oncology deals in 2025 spotlight where industry leaders are betting bigAstraZeneca and Daiichi Sankyo's Enhertu recommended for approvalTen drugs to watch in 2025: will these therapies become blockbusters?

“We were able to show multiple datasets that actually deliver against this vision that antibody drug conjugates can improve on and therefore displace chemotherapy” says Dr. Susan Galbraith, AstraZeneca’s EVP of oncology R&D. Galbraith joins Bloomberg Intelligence analyst Sam Fazeli to break down key findings from ESMO — from early-line HER2 breast cancer data to progress in bladder and lung cancer. She details the promise of Enhertu and Datopotamab, AstraZeneca’s antibody-drug conjugates (ADCs), and how their work may transform cancer treatment in curative settings.See omnystudio.com/listener for privacy information.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Recent developments in these industries underscore a period of significant scientific progress, regulatory maneuvers, and strategic investments.One notable event was AstraZeneca and Daiichi Sankyo's success at the European Society for Medical Oncology Congress 2025. Their antibody-drug conjugate, Datroway, demonstrated superior efficacy compared to Gilead's Trodelvy in the first global head-to-head trial involving Trop2-targeted therapies. This reflects the increasing focus on antibody-drug conjugates as precision medicine tools that offer targeted treatment options with potentially improved outcomes over traditional chemotherapy.In a move highlighting the ongoing trend of bolstering domestic production capacities, Merck is making a substantial $3 billion investment in a small molecule drug plant in Virginia. This is part of a broader $70 billion commitment to expand manufacturing and R&D capabilities in the U.S. Such strategic investments are crucial for maintaining competitive advantage and ensuring drug availability while meeting rising demands and streamlining supply chains.Turning to regulatory updates, the FDA has approved Amgen and AstraZeneca's Tezspire for chronic rhinosinusitis with nasal polyps. This marks Tezspire's second indication, following its initial approval for severe asthma in 2021. The expanded approval showcases the drug's versatility and represents a strategic push to enhance its market presence against competitors like Dupixent.In oncology, Merck's Keytruda and Astellas/Pfizer's Padcev have made headlines with compelling results in muscle-invasive bladder cancer. The combination therapy reduced the risk of death by 50%, reinforcing Keytruda's position as a cornerstone immunotherapy across multiple cancer types. This result not only augments treatment options but also signifies the potential for combination regimens to enhance patient outcomes.Roche has expanded the indication of its aging oncology drug Gazyva to treat lupus nephritis, demonstrating strategic repurposing efforts to extend the lifecycle of existing therapies. While this expansion into autoimmune diseases comes late in Gazyva's lifecycle, it highlights a growing trend of capitalizing on established drugs for new therapeutic areas.AstraZeneca and Daiichi Sankyo's Enhertu showed robust efficacy in early breast cancer treatment, potentially reshaping therapeutic strategies by offering new hope for early intervention. Similarly, Novartis' Pluvicto demonstrated promise in slowing hormone-sensitive prostate cancer progression, underscoring the potential of radioligand therapies in oncology.However, not all developments have been positive. AstraZeneca faced setbacks when its Imfinzi and Lynparza combination failed to meet survival goals in ovarian cancer, underscoring the challenges inherent in oncology drug development and the stringent benchmarks set by regulatory authorities like the FDA.The industry is also witnessing significant advancements in next-generation ADCs, as evidenced by Tubulis' 59% response rate in early clinical trials, which has attracted substantial investor interest. Additionally, Grail's Galleri cancer blood test is progressing towards FDA review with enhanced performance data, potentially revolutionizing cancer screening and early detection practices.These scientific and regulatory milestones are complemented by strategic investments in bioconjugation technologies. Cohance Life Sciences' $10 million investment in NJ Bio to enhance GMP bioconjugation capabilities exemplifies this trend. Such investments are crucial for advancing ADC development, which remains a focal point for innovative cancer therapies.Overall, these developments reflect a dynamic phase for the pharmaceutical and biotech sectors characterized by signSupport the show

Two Onc Docs, hosted by Samantha A. Armstrong, MD, and Karine Tawagi, MD, is a podcast dedicated to providing current and future oncologists and hematologists with the knowledge they need to ace their boards and deliver quality patient care. Dr Armstrong is a hematologist/oncologist and assistant professor of clinical medicine at Indiana University Health in Indianapolis. Dr Tawagi is a hematologist/oncologist and assistant professor of clinical medicine at the University of Illinois in Chicago. In this episode, OncLive On Air® partnered with Two Onc Docs to feature a comprehensive review of the current management of metastatic breast cancer, emphasizing evidence-based treatment strategies across molecular subtypes, toxicity management, and patient-centered care. Drs Armstrong and Tawagi discussed that the primary goals of metastatic breast cancer therapy include prolonging survival, controlling symptoms, minimizing toxicity, improving quality of life, and incorporating patients' goals and preferences into care decisions. Their discussion also highlighted the importance of recognizing when transitioning to best supportive care is most appropriate. For estrogen receptor–positive metastatic breast cancer, they noted that first-line therapy includes an aromatase inhibitor or fulvestrant (Faslodex) combined with a CDK4/6 inhibitor, with ovarian function suppression for premenopausal patients. PARP inhibitors are recommended for patients with BRCA1/2-positive disease. In visceral crisis, chemotherapy remains the category 1 recommendation. Second-line treatment options include therapies guided by repeat molecular testing. fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) is approved for patients with HER2-low disease. For HER2-positive metastatic breast cancer, first-line treatment consists of a taxane plus pertuzumab (Perjeta) and trastuzumab (Herceptin), followed by T-DXd in the second-line setting. For triple-negative metastatic breast cancer, therapy depends on PD-L1 status. The episode concluded by underscoring the role of bone-protective agents such as zoledronic acid, pamidronate, or denosumab (with dental clearance to prevent osteonecrosis). Key takeaways emphasize tailoring therapy to molecular subtype, recognizing drug-specific toxicities, and prioritizing patient-centered decision-making in the management of metastatic breast cancer.

Send us a textIn our Season 11 opening episode, we're bringing you the latest updates from the 2025 ASCO Annual Meeting on metastatic breast cancer. Dr. Ashley Schreier, breast oncologist at Weill Cornell Medicine, breaks down key research and explains what it could mean for people living with MBC.Topics include:Research results for hormone therapy options like camizestrantThe role of ESR1 mutation testingResults from treatment combinations like Enhertu and Perjeta, and Trodelvy and KeytrudaHow to navigate clinical trial accessTips for staying hopeful while exploring treatment optionsWhether you're a patient, caregiver, or advocate, this episode is packed with insights to help you stay informed and empowered.

This week, the American FDA announced it's set to review a new breast cancer drug, Enhertu, developed by AstraZeneca (AZN) and its Japanese partner, Daiichi Sankyo. Julian Hofmann and Dan Jones unpack what this did to Astra's shares, the wider issues facing pharmaceutical companies, plus an update on GSK's (GSK) newest CEO.Next, our Big Read on the ways to effectively pass on your wealth. In the UK, estimates suggest up to £7tn could be transferred from older to younger generations over the next 30 years. Val Cipriani, author of the piece, explains what the “Great Wealth Transfer” means for investors, the trade-off gifters need to consider, and more. Last up, results from Ceres Power (CWR) came in lower than expected. Mark Robinson unpacks the reasons behind it, German shareholder Bosch's departure, and where the valuation stands.Timestamps1:23 AstraZeneca14:53 Passing on wealth 27:40 Ceres PowerRead more on these topics:A pharma giant with star quality How to pass on wealth to your childrenCeres Power cuts revenue guidance for 2025 Hosted on Acast. See acast.com/privacy for more information.

Antibody-drug conjugates (ADCs) are a relatively new type of medicine for breast cancer. Enhertu (chemical name: fam-trastuzumab-deruxtecan-nxki) and Dato-DXd (brand name: Datroway) are two ADCs used to treat breast cancer. Dr Benjamin Schrank and colleagues have developed a new type of ADC that combines an antibody with a toxin — called an antibody-toxin conjugate — that teaches the immune system to recognize and attack cancer cells. Listen to the episode to hear Dr. Schrank explain: the antibody and the toxin component of the medicine how the new medicine works possible side effects next steps for the research Episode image photo credit: The University of Texas MD Anderson Cancer Center

“Colorectal cancer treatment is not just about eliminating a disease. It's about preserving life quality and empowering patients through every phase. So I think nurses are really at the forefront that we can do that in the oncology nursing space. So from early detection to survivorship, the journey is deeply personal. Precision medicine, compassionate care, and informed decision-making are reshaping outcomes. Treatment's just not about protocols. It's about people,” ONS member Kris Mathey, DNP, APRN-CNP, AOCNP®, gastrointestinal medical oncology nurse practitioner at The James Cancer Hospital of The Ohio State University Wexner Medical Center in Columbus, told Jaime Weimer, MSN, RN, AGCNS-BS, AOCNS®, manager of oncology nursing practice at ONS, during a conversation about colorectal cancer treatment.  Music Credit: “Fireflies and Stardust” by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0  Earn 1.0 contact hour of nursing continuing professional development (NCPD) by listening to the full recording and completing an evaluation at courses.ons.org by August 1, 2026. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation. Learning outcome: Learner will report an increase in knowledge related to the treatment of colorectal cancer. Episode Notes  Complete this evaluation for free NCPD. ONS Podcast™ episodes: Episode 370: Colorectal Cancer Screening, Early Detection, and Disparities Episode 153: Metastatic Colorectal Cancer Has More Treatment Options Than Ever Before ONS Voice articles: Colorectal Cancer Prevention, Screening, Treatment, and Survivorship Recommendations Genetic Disorder Reference Sheet: Lynch Syndrome (Hereditary Nonpolyposis Colorectal Cancer) How Liquid Biopsies Are Used in Cancer Treatment Selection Oncology Drug Reference Sheet: 5-Fluorouracil Oncology Drug Reference Sheet: Oxaliplatin What Is a Liquid Biopsy? Clinical Journal of Oncology Nursing article: Colorectal Cancer in Young Adults: Considerations for Oncology Nurses Oncology Nursing Forum article: Neurotoxic Side Effects Early in the Oxaliplatin Treatment Period in Patients With Colorectal Cancer ONS Colorectal Cancer Learning Library ONS Biomarker Database (filtered by colorectal cancer) ONS Peripheral Neuropathy Symptom Interventions American Cancer Society colorectal cancer resources CancerCare Colorectal Cancer Alliance Colorectal Cancer Resource and Action Network Fight Colorectal Cancer National Comprehensive Cancer Network To discuss the information in this episode with other oncology nurses, visit the ONS Communities.  To find resources for creating an ONS Podcast club in your chapter or nursing community, visit the ONS Podcast Library. To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org. Highlights From This Episode “Colorectal cancer has several different types, but there is one that dominates the landscape, and that is adenocarcinoma. So I think most of us have heard that. It's fairly common, and it accounts for about 95% of all colorectal cancers. It begins in the glandular cells lining the colon or rectum and often develops from polyps, in particular adenomatous polyps.” TS 1:41 “One of the biomarkers that we'll most commonly hear about is KRAS or NRAS mutations. This indicates tumor genetics, and these mutations suggest resistance to our EGFR inhibitors such as cetuximab. BRAF mutation or V600E is a more aggressive tumor subtype, and those may respond to our BRAF targeted therapy. … And then our MSI-high or MMR-deficient—microsatellite instability or mismatch repair deficiency—that really predicts an immunotherapy response and may indicate Lynch syndrome, which is a huge genetic component that takes a whole other level of counseling and genetic testing with our patients as well.” TS 6:02 “Polypectomy or a local excision—that removes our small tumors or polyps during that colonoscopy. And that's what's used for those stage 0 or early stage I cancers. A colectomy removes part or all of the colon. This may be open or laparoscopic. It can include a hemicolectomy, a segmental resection, or a total colectomy, so where you take out the entire part of the colon. A proctectomy removes part or all of the rectum. This may include a low anterior resection, also known as an LAR … or an abdominal perineal resection, which is an APR. … Colostomy or ileostomy—that diverts the stool to an external bag via stoma. Sometimes this is temporary or permanent depending on the type of surgery.” TS 14:11 “We'll have our patients say, ‘Hey, I want immunotherapy therapy. I see commercials on it that it works so well.' We have to make sure that these patients are good candidates for it, also that we're treating them adequately. We need to make sure that they have those biomarkers, so as I mentioned, the MSI-high or MMR tumors. Our MSS-stable tumors—they may benefit from newer combinations or clinical trials. Metastatic disease—immunotherapy may be used alone or with other treatments. And then in the neoadjuvant setting, some trials are really showing promising results using immunotherapy prior to surgery.” TS 25:38 “Antibody-drug conjugates are really an exciting frontier in all cancer treatments as well as colorectal cancer treatment. This is used mainly for patients with advanced or treatment-resistant disease, and these therapies combine the targeted power of monoclonal antibodies with the cell-killing ability of potent chemotherapy agents. They're still on the horizon for the most part in colorectal cancer. However, there is only one approved antibody-drug conjugate, or ADC, at this time, and that's trastuzumab deruxtecan, or Enhertu. That's approved for any solid tumor, such as colorectal cancer with HER2 IHC 3+. So again, looking back at that pathology in those markers, making sure that you have that HER2 mutation and that IHC.” TS 35:00 “There are a few myths going around about colorectal cancer treatment that can lead to confusion or even delayed care. One myth is only older men get colorectal cancer. As you heard me talk in my previous podcast on screening, unfortunately, this isn't necessarily true. Colorectal cancer affects both men and women and our cases in the younger population are rising. So our screening guidelines have changed to age 45 because we are seeing it in the younger population.” TS 45:54

Sophie Blake, who lives with secondary breast cancer, talks to Laura about Breast Cancer Now's campaign to make sure everyone with breast cancer across the UK can get access to the drugs they need to survive. Eleanor from Breast Cancer Now also joins the conversation to explain the issues with the drug approval system in England, Wales and Northern Ireland, and what work Breast Cancer Now is doing to help change things. Help us take action now with our automatic form that contacts your MP asking them to help fix the system. Find out more about Breast Cancer Now's campaign, #MoreTimeToLive You can follow Sophie Blake on X @sophieRblake and Instagram @sophieblake72. If you'd like to find out more about Breast Cancer Now's support services, visit the Breast Cancer Now website or phone our free helpline on 0808 800 6000 (UK only). You can subscribe to this podcast on Spotify, Apple Podcasts, or wherever you get your podcasts. Every episode is available to watch or listen to on the Breast Cancer Now website. You can also watch it on YouTube. Key Topics: 2:01 Sophie explains what secondary breast cancer means to her 3:23 The importance of access to breast cancer drugs 4:54 The meaning of "More Time To Live" 6:44 Enhertu: a drug that was rejected for use on the NHS in England 10:10 Eleanor outlines the problem with drugs not being approved 13:07 The Severity Modifier, explained 18:38 The reality that people are dying of breast cancer every day 22:23 Breast Cancer Now's recommendations to MPs to help change the system 25:49 The response to the campaign so far from Wes Streeting and NICE 28:21 The timescales required for change 34:33 How listeners can get involved in the More Time To Live campaign 37:31 Sophie talks about the impact of her campaigning on her family 42:39 What it means to Eleanor to live well 44:30 What it means to Sophie to live well

In this episode, CancerNetwork® spoke with breast oncologists Heather McArthur, MD; Erika Hamilton, MD; Hope Rugo, MD; and Paolo Tarantino, MD, PhD, about advances in breast cancer. These developments included recent drug approvals and ongoing research for therapeutic approaches, particularly in the areas of antibody-drug conjugates (ADCs) and CDK4/6 inhibitors, based on presentations they gave at the 25th Annual International Congress on the Future of Breast Cancer (IBC) East in New York City. Initially, McArthur, Komen Distinguished Chair in Clinical Breast Cancer Research at the Harold C. Simmons Comprehensive Cancer Center, discussed immunotherapy use in high-risk triple-negative and HER2-positive disease, the evolving role of adjuvant CDK4/6 inhibition in HER2-negative breast cancer, and potentially transformative advancements in early breast cancer treatment.  She highlighted the FDA approval for pembrolizumab (Keytruda) in early-stage triple-negative breast cancer, promising clinical trials in estrogen receptor (ER)–positive high-risk early-stage breast cancer, and data from an investigator-initiated trial to treat HER2-positive disease. Additionally, she highlighted an 8.5% improvement in pathological complete response with pembrolizumab added to immunotherapy in the phase 3 KEYNOTE-756 trial (NCT03725059), adding that a further event-free survival benefit may complicate the landscape for CDK4/6 inhibition based on lung and liver toxicities associated with the coadministration of these inhibitors with immunotherapy.1 McArthur expressed further excitement for ADC-based combinations for triple-negative disease, as well as in the high-risk residual disease setting. In addition, she highlighted potential advancements in de-escalation strategies and further considerations for ADCs in the HER2-positive and hormone receptor (HR)–positive spaces. Then, Hamilton, director of Breast Cancer and Gynecologic Cancer Research at the Sarah Cannon Research Institute, highlighted emerging therapies for early breast cancer, as well as her use of datopotamab deruxtecan-dlnk (dato-DXd; Datroway) and fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) given their recent approvals in various breast cancer subtypes. She also touched upon challenges with respect to the implementation of new therapies for early breast cancer into clinical practice. She initially highlighted new data from the phase 3 VERITAC-2 trial (NCT05654623) presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.2 Specifically, findings showed that vepdegestrant, an oral proteolysis-targeting chimera (PROTAC), exhibited an efficacy advantage over fulvestrant (Faslodex) in patients with ESR1-mutant ER-positive, HER2-negative advanced or metastatic disease. Moreover, she highlighted data from the phase 3 DESTINY-Breast09 (NCT04784715) of T-DXd in various combinations for patients with HER2-positive metastatic breast cancer.3 Hamilton further highlighted her implementation of T-DXd into clinical practice, citing her use of the agent in patients with metastatic disease, including those with HER2-low and HER2-ultralow breast cancer. She further differentiated dato-DXd from T-DXd, suggesting that they were different classes of drugs due to their different targets: TROP2 vs HER2. She concluded by highlighting an unmet need regarding sustained benefit from endocrine therapy in HR-positive disease, as well as for ADC sequencing and mechanisms of resistance. Afterward, Rugo, division chief of Breast Medical Oncology, Women's Cancer Program Director, and professor in the Department of Medical Oncology and Therapeutics Research at City of Hope, discussed efficacy and safety considerations for CDK4/6 inhibitors in early breast cancer treatment. Specifically, she highlighted their high tolerability despite adverse effects and costs associated with their use. Rugo further touched upon a reduction of recurrence rates associated with CDK4/6 inhibition, although longer-term follow-up data were warranted to optimize the duration of therapy and elucidate survival outcomes. Finally, Tarantino, a research fellow at the Dana-Farber Institute, concluded by discussing sequencing strategies for ADCs, as well as which breast cancer settings or patient populations will experience the greatest impact with this treatment modality. Tarantino discussed his use of the “sandwich strategy,” where he switches the mechanism of action of treatment after using a TOPO1 ADC. Furthermore, Tarantino highlighted data from the DESTINY-Breast09 and phase 3 ASCENT-04 (NCT06100874) trials, which displayed the enhanced efficacy of 2 ADC combination therapies.4 He concluded by discussing future considerations for combining multiple ADCs. References 1. Cardoso F, O'Shaughnessy J, Liu Z, et al. Pembrolizumab and chemotherapy in high-risk, early-stage, ER+/HER2- breast cancer: a randomized phase 3 trial. Nat Med. 2025;31(2):442-448. doi:10.1038/s41591-024-03415-7 2. Hamilton E, De Laurentiis M, Jhaveri K, et al. Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer: results of the global, randomized, phase 3 VERITAC-2 study. J Clin Oncol. 2025;43(suppl 17):LBA1000. doi:10.1200/JCO.2025.43.17_suppl.LBA1000 3. Tolaney S, Jiang Z, Zhang Q, et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): interim results from DESTINY-Breast09. J Clin Oncol. 2025;43(suppl 17):LBA1008. 4. Tolaney SM, de Azambuja E, Kalinsky K, et al. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. J Clin Oncol. 2025;43(suppl 17):LBA109. doi:10.1200/JCO.2025.43.17_suppl.LBA109

In today's episode, supported by Daiichi Sankyo, we had the pleasure of speaking with Misako Nagasaka, MD, PhD, about the use of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in pretreated patients with HER2-mutated non–small cell lung cancer (NSCLC). Dr Nagasaka is an associate professor in the Division of Hematology and Oncology and the Division of Medicine at the University of California Irvine School of Medicine. In our exclusive interview, Dr Nagasaka discussed current second-line treatment standards for patients with HER2-mutated NSCLC, how the use of T-DXd in this setting may evolve with the emergence of investigational agents, and the importance of integrating HER2 immunohistochemistry testing into clinical practice.

Each year, the American Society of Clinical Oncology annual meeting brings together the biggest names and brightest minds in cancer research, and this year was no exception. In this episode of "The Top Line," Fierce reporters take you inside the action at ASCO 2025. Zoey Becker shares the story behind Johnson & Johnson’s dramatic “Breathtaking” campaign, staged on the 99th floor of Chicago’s Willis Tower. Angus Liu breaks down phase 3 data on Enhertu from AstraZeneca and Daiichi Sankyo, while Gabrielle Masson overviews Bicara Therapeutics' investigational asset for head and neck squamous cell carcinoma. Plus, the team compares notes from the ASCO exhibit hall. To learn more about the topics in this episode: ASCO: AstraZeneca, Daiichi flex Enhertu's muscles in first-line breast cancer as they drop new phase 3 gastric cancer data 'Our data is resonating far more with the people that matter,' Bicara CEO says amid Merus race ASCO: J&J highlights Rybrevant-Lazcluze combo in 'Breathtaking Moments' lung cancer campaign high over Chicago skyline See omnystudio.com/listener for privacy information.

The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting featured five days of presentations and educational sessions on all types of cancer. Dr. Eleonora Teplinsky, a board-certified medical oncologist at the Valley-Mount Sinai Comprehensive Cancer Center in Paramus, NJ, summarizes the top breast cancer research. Listen to the episode to hear Dr. Teplinsky discuss: The SERENA-6 trial, which found that if metastatic hormone receptor-positive, HER2-negative breast cancer develops ESR1 mutations during first hormonal therapy treatment, switching to camizestrant from an aromatase inhibitor before the cancer grows improves outcomes. Results from the DESTINY-Breast09 trial showing that the combination of Enhertu (chemical name: fam-trastuzumab-deruxtecan-nxki) and Perjeta (chemical name: pertuzumab) is a better first treatment for metastatic HER2-positive breast cancer than the current standard of THP chemo.  The ASCENT-04/KEYNOTE-D19 trial, which found that people with metastatic, PD-L1-positive, triple-negative breast cancer fared better with the combo of Trodelvy (chemical name: sacituzumab govitecan-hziy) and Keytruda (chemical name: pembrolizumab) as a first treatment compared to people who received chemotherapy and Keytruda.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Roche and Regeneron are both investing heavily in US manufacturing, with Roche committing $50 billion and Regeneron signing a $3 billion deal with Fujifilm. This move comes as Trump's tariffs threaten the industry. Meanwhile, Pfizer, Alnylam, and BridgeBio are competing in the market for ATTR-CM treatment, with Alnylam and BridgeBio vying for patients switching from Pfizer's tafamidis drug and all three companies seeking new patients.Novo Nordisk has filed for FDA approval of an oral weight loss pill, AstraZeneca and Daiichi Sankyo are pushing their drug Enhertu for frontline breast cancer treatment, and Gilead's Trodelvy in combination with Keytruda has shown promise in slowing disease progression in triple-negative breast cancer. Wacker Biotech is offering services for advanced therapies, while Tempest has recently laid off 80% of its workforce.The industry is facing regulatory challenges and economic uncertainty, with Trump's tariffs potentially impacting pharma companies. Lilly has promised to manufacture a weight-loss pill in the US following a phase III win, and Makary discusses rare disease approvals and public distrust in a new interview. Biotech's future may be more focused on American companies according to PitchBook.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Pfizer and Eli Lilly are considering reshoring manufacturing in the U.S. in response to President Trump's tariff threats. Biohaven faces setbacks in clinical trials, while Roche gains FDA approval for a stroke drug expansion. Startup Delphia aims to use a precision medicine approach to target cancer cells. Industry leaders will discuss orphan drug development at the World Orphan Drug Congress 2025. Other news includes Beigene's label expansion, AstraZeneca and Daiichi Sankyo's success with Enhertu in stomach cancer, and Atara's restructuring.

In today's episode, we had the pleasure of speaking with Aditya Bardia, MD, MPH, FASCO, about the FDA approval of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for the treatment of adult patients with unresectable or metastatic, hormone receptor–positive, HER2-low or -ultralow breast cancer, as determined by an FDA-approved test, that has progressed on at least 1 endocrine therapy in the metastatic setting. Dr Bardia serves as a professor in the Department of Medicine in the Division of Hematology/Oncology and is the director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center. In our exclusive interview, Dr Bardia discussed the significance of this approval, findings from the pivotal DESTINY-Breast06 trial (NCT04494425), and what this new indication for T-DXd means for the future of HER2 testing in breast cancer.

Ozempic gains expanded approval; MS treatment gets Boxed Warning added to label; Monotherapy approval granted for treatment resistant depression Tx Spravato; Leqembi gains  maintenance regimen; Enhertu gains new Breast CA indication.  

In today's episode, we had the pleasure of speaking with David Gerber, MD, a professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center, a member of its Division of Hematology/Oncology, and co-director of Education and Training for the Harold C. Simmons Comprehensive Cancer Center in Dallas. In our exclusive interview, Dr Gerber discussed the evolving role of antibody-drug conjugates (ADCs) in non–small cell lung cancer (NSCLC), focusing on findings from key clinical trials. He highlighted results from the phase 3 TROPION-Lung01 trial (NCT04656652), which demonstrated a modest improvement in progression-free survival with datopotamab deruxtecan-dlnk (Datroway), a TROP2-directed ADC, compared with docetaxel in patients with previously treated advanced NSCLC. He also emphasized the toxicity profile of TROP2-directed ADCs, particularly gastrointestinal toxicities and myelosuppression. Dr Gerber also reviewed the phase 2 HERTHENA-Lung01 trial (NCT04619004) evaluating patritumab deruxtecan in patients with EGFR-mutant NSCLC and the phase 2 DESTINY-Lung02 trial (NCT04644237) assessing fam-trastuzumab deruxtecan-nxki (Enhertu) in those with HER2-mutant NSCLC. Dr Gerber reflected on the shared DXd payload of these ADCs, highlighting its implications for toxicity and efficacy, as well as open questions regarding treatment sequencing and resistance mechanisms.

En este episodio, cubrimos las noticias más relevantes que están impactando los mercados financieros, la inteligencia artificial y la industria de la salud: Rebote en los mercados: Tras la venta masiva del lunes, el Nasdaq y el $SPX se recuperan con $NVDA subiendo un 5% en premercado. Analizamos el impacto de DeepSeek-R1 y la expectativa por los reportes de ganancias de $MSFT, $META, $TSLA y $AAPL. Energía e infraestructura en IA: Empresas como $VST, $CEG y $PWR se recuperan tras el sacudón tecnológico de DeepSeek. Exploramos cómo la infraestructura energética está evolucionando para soportar el crecimiento de la IA. $SOUN y su movimiento estratégico: SoundHound AI registra una oferta de valores por $500M, lo que presiona a la baja sus acciones. Discutimos las implicaciones de esta venta en el mercado y su estrategia de financiamiento. Alibaba Cloud compite en IA: $BABA lanza Qwen2.5-VL, un modelo que desafía a GPT-4o de $MSFT y Gemini 2.0 de $GOOG en análisis de texto e imágenes. Examinamos cómo Alibaba está posicionando su tecnología en sectores clave. Revolución en oncología: AstraZeneca ($AZN) y Daiichi Sankyo ($DSKYF) reciben aprobación de la FDA para Enhertu, una terapia innovadora contra el cáncer de mama metastásico. Analizamos su impacto en la industria y su potencial en otros tratamientos. Acompáñanos mientras desglosamos estas historias clave y su impacto en los mercados, la tecnología y la salud. ¡Un episodio lleno de información estratégica para inversionistas y entusiastas del sector!

In this episode of Oncology Unplugged, a podcast series from MedNews Week, host Chandler Park, MD, a medical oncologist at the Norton Cancer Institute in Louisville, Kentucky, was joined by Guiseppe Curigliano, MD, PhD, a full professor of medical oncology at the University of Milan, as well as the director of the Early Drug Development Division and co-chair for the Experimental Therapeutics Program at the European Institute of Oncology in Italy.  In this exclusive interview, Drs Park and Curigliano discussed the potential future role of artificial intelligence across oncology disciplines; how advances in precision medicine will help improve patient care; the significance of seeing early research with fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) evolve into the present era, where the agent is FDA approved for the treatment of patients with HER2-positive solid tumors. They also discussed their insights on data from the phase 3 DESTINY-Breast06 trial (NCT04494425) investigating T-DXd in patients with HER2-low or -ultralow, hormone receptor–positive, metastatic breast cancer. 

At the 2024 San Antonio Breast Cancer Symposium, Dr. Aditya Bardia, director of the Breast Oncology Program and Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center, presented results from the DESTINY-Breast06 study, showing that Enhertu (chemical name: fam-trastuzumab deruxtecan-nxki), also called T-DXd, was better than chemotherapy for metastatic, hormone receptor-positive, HER2-low or -ultralow breast cancer that grew after one or more hormonal therapy medicines. Listen to the episode to hear Dr. Bardia explain: results of the study what HER2-low and -ultralow breast cancer is whether people diagnosed with metastatic hormone receptor-positive, HER2-negative breast cancer should have additional HER2 testing

In today's episode, supported by Daiichi Sankyo, we had the pleasure of speaking with Misako Nagasaka, MD, PhD, about the use of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in patients with non–small cell lung cancer (NSCLC). Dr Nagasaka is an associate professor in the Division of Hematology and Oncology and the Division of Medicine at the University of California Irvine School of Medicine.  In our exclusive interview, Dr Nagasaka discussed key findings from the phase 2 DESTINY-PanTumor02 (NCT04482309) and DESTINY-Lung01 (NCT03505710) trials that led to the FDA approval of T-DXd for patients with unresectable or metastatic HER2-positive solid tumors, including those with NSCLC; where next-generation sequencing fits into her clinical practice; and the current role of T-DXd in lung cancer management.

OncLive On Air is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions. In today's episode, we had the pleasure of speaking with Susana M. Campos, MD, MPH, about the role of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in patients with HER2-positive gynecologic cancers. Dr Campos is the clinical director and the director of Educational Initiatives in the Division of Gynecologic Oncology at Dana-Farber Cancer Institute, as well as an assistant professor of medicine at Harvard Medical School in Boston, Massachusetts. In our exclusive interview, Dr Campos discussed the clinical implications of findings from the gynecologic cancer cohorts of the phase 2 DESTINY-PanTumor02 trial (NCT04482309).

Why has a drug that can extend life for advanced breast cancer patients not been made available on the NHS? NICE have made the decision that Enhertu, a drug that can give around an extra six months to live on average, is too expensive. BBC Health Correspondent Cath Burns joined Anita Rani alongside Kate Wills, who has stage 4 cancer and has been campaigning for the drug to be made available.The actor Lesley Manville is currently starring alongside Mark Strong in Robert Icke's adaptation of Oedipus. She plays Jocasta, Oedipus' wife. Lesley joined Nuala McGovern to tell us more about the play, what it's like being back on stage for the first time since 2020, and why she thinks women's stories are being featured more.New podcast The Kill List follows a group of journalists who discovered a page on the dark web detailing requests to have people killed, with women most likely to be the ones targeted. The investigation led to a major international police operation over four years and, at the heart of it are the real people whose lives were seemingly at huge risk. Nuala was joined by the programme's producer Caroline Thornham and Jennifer whose former husband posted a 'hit' for her on this website.Blessing scams are targeting Chinese communities in the UK. They're usually carried out by women in groups of three, approaching people asking for help in Cantonese. Tuyet van Huynh's mother was one of these victims. After she was targeted, Tuyet set out to expose this practice on social media and has since heard from other victims. She speaks to Anita about the impact the crime has had on their family.Death is a subject many people still shy away from, but one woman is determined to change that. Funeral director Inez Capps is on a mission to challenge the taboos around death and demystify an industry often shrouded in mystery. Inez talks to Nuala about how, since the age of 19, she's been working with the deceased, and she's using social media to give people a glimpse behind the scenes — from the care a loved one receives, to tours of the hearse and the embalming suite.Elkie Brooks is the renowned British rock, jazz and blues singer. In a career spanning six decades, she was the biggest selling female British artist and still holds the accolade of the most Top 75 albums among female artists. She began singing professionally aged 15, shared a bill with The Beatles and went on to front the group Vinegar Joe with Robert Palmer, before going solo. She's currently on her Long Farewell Tour and joined Anita in the studio to talk about her career and turning 80 next year.Presenter: Anita Rani Producer: Annette Wells Editor: Rebecca Myatt

Why has a drug that can extend life for advanced breast cancer patients not been made available on the NHS? NICE have made the decision that Enhertu, a drug that can give around an extra six months to live on average, is too expensive. BBC Health Correspondent Cath Burns joins Anita Rani alongside Kate Wills, who has stage 4 cancer and has been campaigning for the drug to be made available.Do you have an 'emotional vampire' in your life? It's that person who can make you feel drained with their negativity, who isn't taking your own emotions into account. It can make for tricky relationships – so how do you identify an emotional vampire, and how do you handle that person? Chartered psychologist and author Suzy Reading joins Anita to discuss, alongside journalist and author Radhika Sanghani.Elkie Brooks is the renowned British rock, jazz and blues singer. In a career spanning six decades, she was the biggest selling female British artist and still holds the accolade of the most Top 75 albums among female artists. She began singing professionally aged 15, shared a bill with The Beatles and went on to front the group Vinegar Joe with Robert Palmer, before going solo. She's currently on her Long Farewell Tour and joins Anita in the studio to talk about her career and turning 80 next year. In the latest in our series on special educational needs and disabilities we speak to the comedian Josephine Lacey. Today, we are looking at a very personal issue which will resonate for some mothers of boys with SEND. Josephine joins Anita in the studio. Presenter: Anita Rani Producer: Emma Pearce

Six years ago, Helen Addis (aka The Titty Gritty) found a lump. Despite having no history of cancer in her family - it was an aggressive form of breast cancer. A week after her diagnosis - she had a masectomy, followed by 18 months of active treatment. Being well under the screening age, the only person who would have found Helen's cancer - was Helen. During her treatment, Helen asked her friends and family if they checked their boobs - and when most of them said no - she made it her mission to spread awareness about checking your breasts. So, she launched the Change+Check campaign - it is a simple sticker which goes on shop and gym changing room mirrors reminding people to check themselves for signs of breast cancer. She also almost got the queen with a pair of boobs on a Royal Mail stamp…This Breast Cancer Awareness month - Helen is part of a campign to make a life-extending drug called ENHERTU available in England, Wales and Northen Ireland. Despite petitions, protests, campaigns and even government pressure the secondary breast cancer community is being met with constant rejection. They are now fundrasing to raise the legal fees to take legal proceedings to continue the fight for those who need this drug urgently and for the thousands upon thousands who will need it in months and years to come. You can read more about the campaign - and donate hereFollow Helen on Instagram @thetittygrittyEmail us on shouldideletethatpod@gmail.comFollow us on Instagram:@shouldideletethat@em_clarkson@alexlight_ldnShould I Delete That? is produced by Faye Lawrence Music by Alex Andrew Hosted on Acast. See acast.com/privacy for more information.

The TROP2 antibody-drug conjugate race has heated up among three Big Pharma companies: Gilead Sciences, AstraZeneca and Merck.  Fierce Pharma's Angus Liu recently took a deep dive into the three TROP2 front-runners. In a feature article, he examined the strengths and potential challenges facing each candidate, as well as the considerations behind their extensive phase 3 programs and their various development strategies. In this week's episode of “The Top Line,” Fierce executive editor Eric Sagonowsky chats with Liu about his feature story on the three TROP2 front-runners. To learn more about the topics in this episode: 3 Big Pharma companies, 33 phase 3 trials: The race for supremacy in an ADC field ASCO: Gilead looks for silver lining in Trodelvy's failed lung cancer trial. But will the FDA play ball? AstraZeneca-Daiichi's Enhertu follow-up Dato-DXd unable to prove overall survival benefit in phase 3 See omnystudio.com/listener for privacy information.

This is the first of the three-part podcast series, Keeping up with the Chemos on Trastuzumab Deruxtecan ENHERTU®. After going over some general information on Trastuzumab Deruxtecan ENHERTU® including when to use the drug, checking patient performance status, toxicity, response rates in breast, and line of therapy and treatment option. The multidisciplinary panel will discuss dosing and drug preparation for giving Trastuzumab Deruxtecan ENHERTU®. The session wraps up with some key take home points on Trastuzumab Deruxtecan ENHERTU®.  2023-2024 SGO Chemotherapy and Targeted Therapies Subcommittee Member and Moderator:Tracilyn Hall, MDSpeakers:Jennifer MacDonald, PharmD, BCOPKathleen Moore, MDBernard Tawfik, MD