Podcasts about enhertu

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!

Following the 2024 San Antonio Breast Cancer Symposium (SABCS), Paolo Tarantino, MD, and Matteo Lambertini, MD, PhD, co-hosted a live X Space with CancerNetwork® and spoke about updated trial findings that may impact the breast cancer treatment paradigm. Tarantino is a clinical research fellow at Dana-Farber Cancer Institute and Harvard Medical School. Lambertini is an associate professor and consultant in medical oncology at the University of Genova – IRCCS Policlinico San Martino Hospital in Genova, Italy. Tarantino and Lambertini highlighted data from various studies that investigators presented at the Symposium, which included results on the use of treatment modalities such as antibody drug conjugates and CDK4/6 inhibitors. Some presentations of interest included the following: ·      Phase 3 DESTINY-Breast06 Trial (NCT04494425) o   Patients with hormone receptor (HR)–positive, HER2-low or HER2-ultralow metastatic breast cancer were assigned to receive fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) or physician's choice of therapy. o   Treatment with T-DXd improved progression-free survival (PFS) among patients with a time to progression on frontline endocrine therapy of less than 6 months (HR, 0.38; 95% CI, 0.25-0.59), 6 to 12 months (HR, 0.69; 95% CI, 0.43-1.12), and more than 12 months (HR, 0.67; 95% CI, 0.51-0.88). o   PFS improved with T-DXd regardless of disease burden. ·      Phase 3 EMBER-3 Trial (NCT04975308) o   Investigators evaluated 3 treatment arms—imlunestrant (LY3484356) monotherapy, fulvestrant (Faslodex) or exemestane (Aromasin), and imlunestrant in combination with abemaciclib (Verzenio)—among patients with estrogen receptor (ER)–positive, HER2-negative advanced breast cancer. o   Across the overall population, imlunestrant monotherapy improved PFS compared with standard endocrine therapy (HR, 0.87; 95% CI, 0.72-1.04; P = .12). o   Imlunestrant plus abemaciclib also showed a PFS improvement vs endocrine therapy across the overall population (HR, 0.57; 95% CI, 0.44-0.73; P

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.

On Friday the 13th September, Pharmac opened consultation for funding of the medication, Enhertu, for HER2-positive metastatic breast cancer. This comes following the $604 million funding boost allocated to Pharmac to fund and widen access to various medicines.  Trials have shown that the drug can reduce risks of breast cancer patients death by 27%. Producer Josef spoke to the Chief Executive of Breast Cancer New Zealand, Ah-Leen Rayner, about the drug's funding, and what more can be done for breast cancer patients.

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 last of the three-part podcast series, Keeping up with the Chemos on Trastuzumab Deruxtecan ENHERTU®. Our multidisciplinary panel will discuss the challenges with patient monitoring while on Trastuzumab Deruxtecan ENHERTU®. When to dose adjust and hold or even discontinue Trastuzumab Deruxtecan ENHERTU®. Once again, the podcast ends with take home points for patient monitoring and side effects while 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 

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 

This is the second of the three-part podcast series, Keeping up with the Chemos on Trastuzumab Deruxtecan ENHERTU®.  Our multidisciplinary panel will discuss the important information about the drug preparation and administration of Trastuzumab Deruxtecan ENHERTU®.  Focusing on dosing, breast scoring, HER2, infusion reactions, lab examinations, and patient education. The session ends with general take home points on administration and toxicity prevention interventions.2023-2024 SGO Chemotherapy and Targeted Therapies Subcommittee Member and Moderator:Tracilyn Hall, MDSpeakers:Jennifer MacDonald, PharmD, BCOPKathleen Moore, MDBernard Tawfik, MD 

Following the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, Neil M. Iyengar, MD, and Paolo Tarantino, MD, co-hosted a live X Space with CancerNetwork® and discussed the latest trial updates that may impact clinical practice in the breast cancer field. Iyengar is an associate attending physician at Memorial Sloan Kettering Cancer Center and a co-editor-in-chief of ONCOLOGY®. Tarantino is a clinical research fellow at Dana-Farber Cancer Institute and Harvard Medical School.  Iyengar and Tarantino discussed data regarding several trials and studies presented at the meeting. These presentations included:  ·      Phase 3 DESTINY-Breast06 Trial (NCT04494425)1 o   Investigators evaluated treatment with trastuzumab deruxtecan (T-DXd; Enhertu) compared with investigator's choice of chemotherapy among patients with hormone receptor (HR)–positive, HER2-low or HER2-ultralow metastatic breast cancer. o   The median progression-free survival (PFS) was 13.2 months with T-DXd compared with 8.1 months in patients who received chemotherapy across the HER2-low population (HR, 0.62; 95% CI, 0.51-0.74; P

Conference season kicked into high gear this week with the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and the BIO International Convention in San Diego. Check out BioSpace's ASCO24 Tracker with all the biggest data and other news from the cancer meeting, which wrapped up on Tuesday. Among the trial results highlighted at ASCO24 were BMS' Phase III study results in liver cancer. There was also a lot of news on non-small cell lung cancer (NSCLC): Pfizer presented results from a Phase III trial evaluating its ALK inhibitor Lorbrena, BMS provided three updates on its immunotherapy Opdivo and Opdivo-based combinations, while Gilead unveiled additional details on a failed Phase III trial for its antibody-drug conjugate (ADC) Trodelvy. Currently, there is one ADC approved to treat NSCLC, AstraZeneca and Daiichi Sankyo's Enhertu, for patients with HER2-mutated metastatic disease. While the companies' investigational ADC Dato-DXd is making some headway against NSCLC, experts recently told BioSpace that more compelling surface targets for lung cancer are needed in order for ADCs to really make a difference. When it comes to M&A, Big Pharma continues to show strong interest in oncology, particularly ADCs and radiopharmaceuticals. However, last week's biggest deal was Merck's $3 billion acquisition of EyeBio and its first-in-class trispecific antibody Restoret, marking the company's return to the ophthalmology space after nearly a decade. For now, it appears Big Pharma favors smaller M&A over megabillion-dollar deals. Recent buying activity also indicates a potential resurgence in the appetites of larger companies for psychiatric drug development.

The 2024 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 explain: the DESTINY- Breast06 study on Enhertu compared to chemotherapy for metastatic hormone-receptor-positive breast cancer how circulating tumor DNA may help predict recurrence descalating treatment to reduce the risk of side effects

Wat doe je als je ziek bent en er in het buitenland een behandeling beschikbaar is die jouw leven kan redden? In BNR Beter twee patiënten die dit overkwam. Waar liepen deze twee ondernemende patiënten tegenaan?  Dwarslaesie De eerste gast is Katelijne Langezaal. Zij brak haar rug in 2016 tijdens een zeiltocht. Het resulteerde in een dwarslaesie: vanaf haar navel tot aan haar tenen was ze verlamd. De reguliere dwarslaesiebehandeling in Nederland gaat langs het revalidatiecentrum waar je leert om te gaan met je beperking: hoe kom je van je rolstoel naar je bed en terug?  Activity Based Therapy Maar in Amerika bleek er een behandeling te zijn die probeert om weer gevoel en functie terug te krijgen onder de dwarslaesie. Dit is Activity Based Therapy. Katelijne zette alles op alles om die behandeling voor zichzelf te organiseren. Dat lukte, met hulp van haar zorgverzekeraar en vrienden en familie. Neuromove En ze ging nog een stap verder: ze richtte een stichting op die deze behandeling in Nederland ging aanbieden, genaamd Neuromove. In de reportage horen we een van de cliënten van Neurmove, Menno Streefland die 20 uur in de week traint om weer zelfstandig te kunnen lopen.  Kanker De tweede gast is Lotte ten Dam. Zij heeft uitgezaaide borstkanker. Om de groei van de kanker te onderdrukken heeft chemotherapie nodig. Tot nu toe werkt de huidige therapie, maar op een gegeven moment gaat de kanker hier doorheen breken. In medische tijdschriften (die Lotte kan lezen omdat ze verpleegkundig specialist is) ontdekte ze een goedgekeurd kankermedicijn dat haar naar verwachting 28 stabiele maanden kan geven. 28 maanden zonder uitzaaiingen en dus een enorm uitstelt tot die onherroepelijke dood. Sluis Een probleem: het medicijn, Enhertu, stond 'in de sluis'. Het medicijn was heel duur, en de overheid moest over de prijs onderhandelen met de farmaceut. Maar het zat al een hele tijd in die sluis. En Lotte's tijd begon te tikken. Tijd voor actie dus! Influencer? 'Je moet zorgen dat je viraal gaat', zei een vriendin tegen Lotte. 'Word ik echt zo iemand?', vroeg Lotte zich af. Maar als je leven in de waagschaal ligt, stap je toch net iets makkelijker over je gêne heen. Ze ging brieven schrijven aan de ministers, Kamerleden en zocht de pers op.  Toevallig of niet, kwam het medicijn niet lang daarna uit de sluis. En nu ligt het op de plank voor Lotte en vele andere mensen met allerlei vormen van kanker.     Presentator: Nina van den Dungen Redactie en reportage: Sterre ten Houte de LangeSee omnystudio.com/listener for privacy information.

Listen to a soundcast of the April 5, 2024, FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-positive solid tumors.

In their recent earnings call, AstraZeneca, led by CEO Pascal Soriot, shared their financial performance and future strategies with investors. The dialogue underscored both the company's recent progress and its forward-looking plans within the context of the global healthcare sector.AstraZeneca reported notable financial performance, with a 19% increase in overall revenue and a 13% rise in core earnings per share. Their growth has been further bolstered by an 18% increase in product sales, indicating a wholesome financial status. AstraZeneca points to key products, such as Tagrisso, Lynparza, Imfinzi, Calquence, Enhertu, and Ultomiris, as significant contributors to the company's expansion. Furthermore, new additions like Tagrisso combined with chemotherapy and the HER2 tumor-agnostic solution have supplemented the company's product assortment.Consumer trends, as presented by AstraZeneca during their earnings call, depict a robust demand for their pharmaceuticals across various therapeutic areas, including oncology, biopharma, and rare diseases. The company's growth, driven by such widespread demand, suggests a solid market position, based on the evidence from the earnings call.Furthermore, AstraZeneca has demonstrated a commitment to strategic investments, as can be inferred from their involvement in Fusion Pharmaceuticals and Amolyt Pharma. The company's emphasis on diversification and capability enhancement appears to be a primary goal. In the same vein, AstraZeneca's focus on spearheading eight pivotal trials and exploring emerging fields like cell and gene therapies positions them as a potential leader in oncology and beyond.Soriot, during the earnings call, provided insights into the company's perspective, stating, "And we'll keep that in mind as we continue to design our clinical development program." It indicates AstraZeneca's ongoing commitment to optimizing their clinical development strategy to address evolving healthcare requirements. However, while AstraZeneca has demonstrated success in recent periods, it is essential to remember that the path forward – full of challenges and opportunities – in the extremely competitive and complex healthcare sector is by no means certain and the decisions and strategies announced during this call constitute only the company´s current view and could be subject to changes. AstraZeneca's future performance should be observed in this context of uncertainty inherent to the pharmaceutical industry. This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.theprompt.email

·       Nascentmc.com for medical writing assistance for your company.Visit nascentmc.com/podcast for full show notes Cilta-cel for Myeloma: The FDA approved ciltacabtagene autoleucel (Carvykti; cilta-cel) for adults with relapsed or refractory multiple myeloma who have tried at least one prior therapy including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. This CAR T-cell therapy, initially approved in 2022, was confirmed effective in the phase 3 CARTITUDE-4 study, showing significant reduction in disease progression or death risk by 59% compared to standard care. Enhertu for HER2-positive Solid Tumors: Fam-trastuzumab deruxtecan-nxki (Enhertu) received FDA approval for treating unresectable or metastatic HER2-positive solid tumors in adults who have had previous systemic treatment and lack satisfactory alternative options. This therapy, a conjugate of an anti-HER2 antibody and a cytotoxic drug, was first approved in 2019 and targets HER2-expressing cancer cells to potentially minimize damage to normal tissues. Fanapt for Bipolar: Iloperidone (Fanapt) has been approved for the acute treatment of manic or mixed episodes in adults with bipolar I disorder. Previously approved for schizophrenia, iloperidone targets neurotransmitters like dopamine and serotonin. It demonstrated efficacy in a pivotal trial, showing significant improvement on the Young Mania Rating Scale. Zevtera for Multiple Bacterial Infections: Ceftobiprole medocaril sodium (Zevtera) was approved for treating adults with Staphylococcus aureus bloodstream infections, right-sided infective endocarditis, and acute bacterial skin and skin structure infections. Also approved for pediatric community-acquired bacterial pneumonia, ceftobiprole is a broad-spectrum cephalosporin that combats various bacteria including MRSA. TriClip for Tricuspid Regurgitation: The FDA approved the TriClip™ transcatheter edge-to-edge repair system for treating tricuspid regurgitation. This minimally invasive option clips the tricuspid valve leaflets to improve blood flow and prevent the need for surgery. The TRILUMINATE Pivotal trial showed significant improvements in TR severity and quality of life with a good safety profile. Revumenib for Acute Leukemia: The FDA granted priority review to revumenib (SNDX-5613) for treating adult and pediatric patients with relapsed or refractory acute leukemia with KMT2A rearrangements. As a new therapeutic agent, revumenib inhibits the menin-MLL protein interaction crucial in leukemic transformation. Early trial results show promising remission rates, with a PDUFA action date scheduled for September 26, 2024.  

In this episode, Laura talks to Hannah Gardner about the life-extending drug Enhertu, which has just been rejected for use on the NHS in England. This means thousands of women, including Hannah, will be denied access to a drug that could've given them the hope of more time to live. Join Hannah and Breast Cancer Now in calling on NICE, NHS England and the drug companies Daiichi Sankyo and AstraZeneca, to do everything possible to make Enhertu available on the NHS. Hannah also shares how life with secondary breast cancer is for her and her 3-year-old daughter. She discusses her previous career as a clinical trials manager, and what it was like to be on the other side of the table when she joined a clinical trial herself. Hannah also describes the devastating impact of finding out she may be denied the drugs that could give her more time. You can follow Hannah on Instagram @realhouseofhannah We're Breast Cancer Now, the research and support charity. However you're experiencing breast cancer, we're here. For information and support, visit our website or phone our free helpline on 0808 800 6000 (UK only). You can also watch this episode on YouTube. Key Topics: 0:00 Introduction 0:24 Laura introduces Hannah 1:00 How Hannah was first diagnosed with breast cancer 3:35 Hannah's treatment 4:01 Difficulty getting the diagnosis 6:08 Hannah talks about being diagnosed with secondary breast cancer 10:36 The effect of the diagnosis on Hannah's daughter 15:33 Treatment for secondary breast cancer 16:07 Hannah's experience with clinical trials 25:01 How breast cancer affected Hannah's body image 29:59 Looking well with an invisible illness 31:40 Enhertu and HER2-low breast cancer 37:31 Breast Cancer Now's Enhertu open letter campaign 39:30 An update on Enhertu and what it means for Hannah 50:38 What you can do to help Breast Cancer Now make a difference 54:01 Differences in how primary and secondary patients are treated 57:46 What needs to change in breast cancer?

Last week, we saw some research regarding how a popular tool used to plan breast cancer treatment may be misguiding therapy for Black women, as well as an update on when we can expect to see a new cancer vaccine be readily available for patients.  And on the FDA front, we'll discuss a priority review for Enhertu for patients with HER2-positive solid cancers, as well as a fast track designation for a new drug duo in the lung cancer space.  Cancer Vaccine Likely ‘Several Years' Away From Wide Availability ELI-002 is a vaccine being investigated for the treatment of patients with KRAS-mutant pancreatic or colorectal cancers. While cancer vaccines have been in the headlines a lot in recent months, this one, at least, is still a ways away from being readily available for patients across the United States.  Findings from a phase 1 trial showed that the vaccine could be beneficial for this patient population, and now, a phase 2 trial recently started that will evaluate the efficacy of an injection version of ELI-002, compared to observation. The first patient was dosed in the trial in January 2024, so it could still be several more years until the drug is available, Dr. Christopher Haqq, chief medical officer and vice president, head of research and development at Elicio Therapeutics, said in an interview with CURE®.  “We'll be talking to the regulators like the US Food and Drug Administration and others around the world to align on the data that we'll need to provide for a marketing application. And so, we haven't had that input yet. So I can't give an exact answer for you (on when the vaccine will be commercially available). But we'll work as fast as possible. It's even possible that the type of evidence that we gather in this randomized study could serve that purpose. But we won't know until we have further discussion,” he said.  Test May Be ‘Misguiding' Breast Cancer Treatment for Black Women  A recent study showed that the 21-gene breast recurrence score may lead clinicians away from prescribing chemotherapy to Black women who may benefit from the treatment.  The 21-gene breast recurrence score is the standard test to help guide treatment decisions for patients with estrogen receptor-positive (also known as ER-positive) disease. Most patients with ER-positive cancer undergo hormone therapy, but the outcomes for this test may help decide if a patient would benefit from additional chemotherapy, too. Now, findings from a recent study discovered that Black women — and younger Black women, in particular — may be missing out on chemotherapy that they could potentially benefit from.  Now, this research team is conducting further research looking at potential molecular differences in breast cancer in Black women, as well as how other social disparities could be playing into an increased risk of breast cancer death in these women.  FDA Grants Priority Review to Enhertu for HER2-Positive Solid Cancers  The Food and Drug Administration granted a priority review for a supplemental biologics license to Enhertu for the treatment of patients with previously treated metastatic HER2-positive solid tumors that cannot be removed via surgery. Basically what that means is that the drug showed promise in a clinical trial, and now the FDA will work with the pharmaceutical company developing the drug to expedite the review and potential approval of the agent. The agency plans on making its decision on whether or not Enertu will be approved some time in the second quarter of this year.  Enertu is an antibody drug conjugate, which is a type of drug that works by finding and binding to certain proteins found on cancer cells — in this case, the HER2 protein. The drug was previously approved for patients with lung cancer and metastatic breast cancer, and now, the phase 2 DESTINY-PanTumo02 trial will help determine if it will be approved for patients with endometrial, cervical, ovarian, bladder, biliary tract, pancreatic or other cancers that are HER2 positive.  FDA Grants Fast Track Designation to Avutometinib-Lumakras Combo Also in the regulatory space, the FDA granted a fast track designation to a two drug combination consisting of Lumakras and the novel agent, avutometinib for patients with KRAS G12C-mutant metastatic non-small cell lung cancer. The intended patient population for the regimen is those who have been treated with at least one systemic therapy and have not received a KRAS G12C inhibitor.  The regimen is being investigated in the ongoing phase 1/2 RAMP 203 trial, which will analyze the effectiveness of the drug, as well as the overall response rate — which is the percentage of patients whose cancer decreases from the drug — and safety. Findings from the second phase of the trial, which is specifically looking at patients who have not received or did not respond to a KRAS G12-inhibitor are expected to be published some time in the first half of 2024.   For more news on cancer updates, research and education, don't forget to subscribe to CURE®'s newsletters here.

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. Today, we have several news updates from the industry. Let's dive in.Cigna has sold its Medicare businesses to HCSC for $3.7 billion, exiting a sector that has seen its earnings potential shrink. Despite the sale, Cigna still sees Medicare Advantage as an area for future growth. In other news, the No Surprises Act prevented 10 million surprise bills in the first nine months of 2023, according to insurer groups AHIP and BCBSA. However, they also criticized providers for allegedly abusing the billing dispute resolution process set up by the law. Tenet Healthcare plans to sell four California hospitals to UCI Health for $975 million as part of its efforts to reduce debt. An AI-powered solution is being touted as a way to alleviate the critical shortage of medical coders and boost efficiency and revenue in healthcare systems.In the biotech world, Arch is raising $3 billion for startup investing, continuing its track record of creating and investing in biotech startups. Vertex's non-opioid drug showed positive results in a major trial for pain relief, although it fell short compared to a widely prescribed opioid on a secondary goal. Cell therapy for lupus is gaining attention, with several drugmakers conducting trials in this area. Biogen has decided to discontinue its controversial drug Aduhelm and return the rights to the original developer. AstraZeneca and Daiichi are seeking FDA approval for their drug Enhertu as a "tumor agnostic" treatment. Roche has made changes to its early-stage pipeline, focusing on experimental programs for obesity.In recent developments, Philips has stopped selling sleep and respiratory devices in the US due to a consent decree from the FDA. Teleflora used a documentary approach in its marketing campaign to overcome cynicism about love, while Lay's released time-loop ads inspired by the movie "Groundhog Day." Ocean Spray revealed its first major brand overhaul in over 20 years, and Miller Lite turned fans into walking beer ads for the Super Bowl. McDonald's also made headlines with its Hamburglar character hitting the road in a getaway vehicle. Pepsi Wild Cherry created excitement around the Super Bowl with a Vegas sphere takeover.Cigna is still interested in the Medicare Advantage market despite selling its Medicare division. Providence plans to settle allegations of not fulfilling charity care obligations. Walgreens has confirmed additional layoffs as part of its ongoing efforts to achieve cost savings. The Department of Health and Human Services has finalized a rule on telehealth at opioid treatment programs. A new study found that the availability of telehealth for mental healthcare varies by state. Healthcare executives must consider workforce and consumer concerns about generative AI, according to a survey.Alto Neuroscience and Fractyl Health have both gone public in separate IPOs, joining the recent surge of biotech IPOs. The CMS has sent initial price proposals to drugmakers as part of efforts to reform drug pricing. Kyverna Therapeutics is planning an IPO to support the development of its anti-CD19 CAR-T therapies. The Department of Health and Human Services released new data showing that Americans pay significantly more for prescription drugs compared to other developed countries. The ASGCT Annual Meeting will cover topics such as genome editing, muscular dystrophy, and cell and gene therapy.In financial news, AbbVie reported a beat in its Q4 earnings but expects sales decline in oncology and immunology. Bristol Myers Squibb exceeded Q4 estimates and is looking towards new products and M&A following exclusivity loss. Merck posted $60 billion in sales for 2023 driven by Keytruda and HPV vaccine. GlaxoSmithKline saw an increase in sales thanks to vaccines for RSV and shingles. Takeda reported lower profits but closed a $300 million deal with Protagonis

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. AstraZeneca, the pharmaceutical company, recently had its day in court regarding a potential injunction on the Medicare drug pricing law. The outcome of the hearing will have significant implications for the healthcare industry. Meanwhile, Vertex Pharmaceuticals' non-opioid pain drug failed to outperform Vicodin in clinical trials, but experts believe that more can be done to develop effective non-opioid pain medications. In other news, a study has found that the Inflation Reduction Act's drug price negotiation program will have only a modest impact on global biopharma revenues and is unlikely to result in significant cuts to research and development. Sanofi reported a $600 million net loss in Q4 2023 due to various factors, despite strong sales of its blockbuster drug Dupixent. Additionally, Roche's 2024 strategy aims to combat low growth through pipeline cuts and mergers and acquisitions. Daiichi Sankyo has raised its sales forecast for Enhertu due to non-US growth, and the FDA Commissioner has highlighted adcomm reform, funding, and AI as priorities for the agency.Moving on to other industries, Pepsi is generating excitement for the Super Bowl with its "Get Wild" campaign for Pepsi Wild Cherry. Gatorade, another brand under PepsiCo, is launching a free membership platform to fuel its digital transformation. Jif, the peanut butter brand, is tackling "celery neglect" on game day by offering free peanut butter through a tie-up with Gopuff. In social media news, CEOs faced tough questions about child protection in a Senate session, with senators arguing that social platforms need to do more to protect young users. Advertiser Perceptions' Erin Firneno advises media companies on how to communicate brand momentum in 2024. The Super Bowl LVIII ads are being tracked, with reveals from Michelob Ultra and Paramount+, and teasers from Uber and Nyx. Google, CrowdStrike, and State Farm will also be returning with ads. Lastly, Marketing Dive's daily newsletter offers insights and news for marketing leaders.In the field of research, BioIVT is a leading provider of control matrices, offering biofluids, tissues, and matrices from commercial animals for research purposes. These biospecimens undergo strict quality control measures to enhance assay sensitivity. BioIVT offers a wide range of control matrices, including serum, cerebrospinal fluid (CSF), ocular fluid, and various tissues. These samples can be shipped fresh, cold, or frozen to ensure reliability and quality. Additionally, BioIVT provides matrices from commercial animals.Thank you for listening to Pharma and Biotech daily. Stay tuned for more important updates in the world of Pharma and Biotech.

In this episode, we delve into the exciting developments in antibody drug conjugates (ADCs) presented at the 2023 San Antonio Breast Cancer Symposium.ADCs are a promising class of treatment that combines an antibody with a chemotherapy drug, aiming to target and kill cancer cells more effectively while reducing side effects. We discuss approved ADCs like Enhertu and Trodelvy, and highlight that there's an ADC available for every breast cancer subtype. With many more ADCs in clinical and preclinical trials, the future looks hopeful for breast cancer treatment.We explain the structure of ADCs, which includes the antibody that targets cancer cells, the cytotoxic drug that kills the cells, and the linker that holds them together. We also touch on the importance of choosing treatment types based on personal circumstances, such as age and family responsibilities, as different treatments come with varying side effects.During the episode, we cover two clinical trials in detail. The first is about Datopotamab Deruxtecan (DATO-DXD), which showed promising results in hormone receptor-positive, HER2-negative patients, offering increased progression-free survival and different side effect profiles compared to traditional chemotherapy. The second trial combined DATO-DXD with the immunotherapy drug Durvalumab for advanced and metastatic triple-negative breast cancer, showing a high response rate and manageable side effects.Our guest, Katie, shares her personal experiences with ADCs and provides insights into side effect management. She emphasizes the importance of dose adjustments and monitoring for specific side effects like nausea, vomiting, and interstitial lung disease. Katie also mentions the ongoing research to optimize dosing, detect side effects earlier, and engineer drugs with lower toxicity.As always, we remind our listeners that the information shared on our podcast is based on personal experiences and is not a substitute for professional medical advice. We encourage you to reach out to your medical care team with any questions or concerns.00:00:47 - Overview of Antibody Drug Conjugates (ADCs)00:03:37 - FDA-Approved ADC Examples00:04:49 - Datopotamab Deruxtecan (DATO-DXD) Clinical Trial Insights00:07:10 - Combining DATO-DXD with Immunotherapy00:08:23 - Managing ADC Side Effects00:09:53 - Specific Recommendations for Current ADCs00:11:09 - Future Directions in ADC Development+++++++++++++++++++++Attend a free virtual SurvivingBreastCancer.org event:https://www.survivingbreastcancer.org/eventsFollow us on InstagramLaura and Will: https://www.instagram.com/laura_and_will/SurvivingBreastCancer.org: https://www.survivingbreastcancer.org/Breast Cancer Conversations: https://www.instagram.com/breastcancerconversations/About SurvivingBreastCancer.org: SurvivingBreastCancer.org, Inc. (SBC) is a federally recognized 501(c)(3) non-profit virtual platform headquartered in Boston with a national and global reach. Through education, community, and resources, SurvivingBreastCancer.org supports women and men going through breast cancer. We provide a sanctuary of strength, compassion, and empowerment, where those diagnosed with cancer unite to share their stories, learn invaluable coping strategies to manage wellness and mental health, and find solace in the unbreakable bond that fuels hope, resilience, and the courage to conquer adversity.Support the show

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Sarepta Therapeutics has released data on its new drug for Duchenne muscular dystrophy, showing potent boosting of dystrophin protein production. However, some side effects, including electrolyte imbalances, were also highlighted. Astrazeneca and Daiichi are seeking FDA approval for their drug Enhertu as a "tumor agnostic" treatment, and the FDA is currently reviewing their application. Bristol Myers has received positive data from a trial of a subcutaneous formulation of Opdivo in kidney cancer, showing similar efficacy to the intravenous formulation. Biotech IPOs continue to be an important source of funding for the industry, with Alto Neuroscience and Fractyl Health preparing for initial stock offerings. Merck Manuals is focusing on a "one health" approach, integrating human, animal, and environmental health in medical education and practice.Philips has announced that it will stop selling sleep and respiratory devices in the US due to a consent decree from the FDA. This decision comes as Philips faces regulatory scrutiny and potential legal action related to quality issues with its sleep apnea devices. Medical device companies Stryker, Boston Scientific, and BD are set to post their earnings this week. Absolutions has received FDA breakthrough designation for its abdominal wall closure device, aiming to reduce the risk of hernia by distributing suture tension over a large area of tissue. Globus has laid off employees from NuVasive following their merger. Masimo has forced Apple to redesign its smartwatches in a long-running patent dispute.The pharmaceutical industry is in a race to develop groundbreaking drugs for pain relief. Tanezumab, developed by Eli Lilly and Pfizer, was dropped due to safety concerns. Attention has turned to Vertex Pharmaceuticals' candidate vx-548, which has shown positive results in phase 2 trials for chronic nerve pain. South Rampart Pharma has won fast track designation for its novel drug that activates pain signaling pathways without causing liver and kidney toxicities. Tonix Pharmaceuticals is repurposing an existing technology for the treatment of fibromyalgia, with positive late-stage results. These developments offer hope for patients suffering from chronic pain conditions and could generate significant revenue for the companies involved.Overall, these developments highlight ongoing challenges and changes in the medtech industry, including regulatory scrutiny, mergers, and patent disputes. Medtech companies must navigate these complexities while leveraging connected ecosystems, data, and strategic planning to drive innovation in healthcare.Thank you for tuning in to Pharma and Biotech daily. Stay informed, stay ahead.

Last week was Veterans' Day, and for some individuals in the armed service, that means reflecting back on their service, as well as the potential cause of their cancer. For both print and web-first features, CURE® spoke with veterans about their cancer journeys, including one Iraq veteran whose cancer was likely caused by exposure during his deployment overseas.  Regarding new drug indications last week, the FDA seemed to be working in the gastrointestinal space: we saw a new drug approved for certain patients with colorectal cancer, and other indication in the gastric cancer space slightly changed from the way it was originally approved a few years ago.  Finally, it is the open enrollment period for people who are eligible for Medicare. We heard from an expert at City of Hope about why patients with cancer should do their research before choosing a plan.  Veteran, Colon Cancer Survivor Explains Importance of PACT Act  Last year, President Joe Biden signed the bipartisan Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act into law last year, with the White House calling it “the most significant expansion of benefits and services for toxic exposed veterans in more than 30 years.” More than 4.1 million veterans received free toxic exposure screenings through the VA, with the government processing nearly half a million PACT Act claims and delivering more than $1.85 billion in PACT Act-related benefits to veterans and survivors, including $215 million in benefits to veterans with cancer, during the first year of the PACT Act, the White House stated. Under the PACT Act, for example, all gastrointestinal cancers are considered toxic exposure presumptive conditions — meaning veterans do not have to prove that the cancer started during or worsened because of their military service — for veterans from the Gulf War and post-9/11 eras such as Dan Nevins, a U.S. Army Reserve veteran and stage 3 colon cancer survivor who served in Iraq. Read more: Veterans On The Front Lines of Lung Cancer Dan is a bilateral, below-knee amputee living with a traumatic brain injury as a result of his service, and he received his cancer diagnosis in late 2021. Spoke with us about his experiences being exposed to burn pits in Iraq. FDA Approves Fruzaqla for Previously Treated Metastatic Colorectal Cancer Last week came with another Food and Drug Administration approval in the oncology space. Fruzaqla for patients with metastatic colorectal cancer that has been previously treated with certain chemotherapy drugs, anti-VEGF therapies, and — if the patient has RAS wildtype disease and its medically appropriate — an anti-EGFR therapy.  The approval, which was announced on Wednesday night, was based on findings from two clinical trials: FRESCO and FRESCO-2, which both showed that Fruzaqla improved overall survival (time from treatment until death of any cause) compared to placebo in this patient population.  Of note, Fruzaqla is an oral drug that is not a chemotherapy agent, which may help patients avoid an abundance of clinics for treatment, as well as some of the side effects associated with chemotherapy, though we should note that Fruzaqla, like all drugs, does have its own set of potential side effects.  FDA Amends Keytruda Approval for Gastric, GEJ Cancer Also on the FDA front, the agency announced on Thursday that it was revising the approval indication of Keytruda plus Enhertu and chemotherapy for the frontline treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.  The Keytruda-containing regimen was originally approved in May 2021 and was for patients regardless of their cancer's PD-L1 status. PD-L1 is a protein found on the surface of tumor cells and acts as a kind of cloak of invisibility from the immune system. Checkpoint inhibitor drugs like Keytruda inhibit the function of PD-L1, thereby allowing the immune system to find and fight the cancer. With the amended approval, the FDA is now stating that this Keytruda regimen should only be used in patients whose cancers have that PD-L1 protein, as determined by a companion diagnostic test.  This change came after follow-up data from the KEYNOTE-811 trial were presented at the European Society for Medical Oncology Congress a couple of weeks ago. The findings showed that while the Keytruda plus Enhertu and chemotherapy improved outcomes over placebo plus Enhertu and chemotherapy, the benefit was particularly better for those whose disease was PD-L1 positive.  When It Comes to Cancer Care, Not All Medicare Plans Are the Same The Medicare open enrollment period has officially begun and will run until Dec. 7.  In a CURE® exclusive article penned by Dr. Harlan Levine of the City of Hope, a popular type of Medicare — Medicare Advantage — is outlined, along with their potential pros and cons when facing a cancer diagnosis. For example, did you know what while Medicare Advantage tends to be a more affordable option, it may not cover research medical centers that provide patients with cancer access to advanced treatments and clinical trials?  Dr. Levine and others are advocating for Medicare Advantage to cover treatment at comprehensive cancer centers, but until then, he warns individuals to be weary of the plans that they choose and always read the fine print.   For more news on cancer updates, research and education, don't forget to subscribe to CURE®'s newsletters here.