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In today's episode, we spoke with Tanios S. Bekaii-Saab, MD. Dr Bekaii-Saab is the David F. and Margaret T. Grohne Professor of Novel Therapeutics for Cancer Research I, at the Mayo Clinic College of Medicine and Science, the division chair of Hematology/Medical Oncology at Mayo Clinic, and co-leader of the Advanced Clinical and Translational Science Program and the disease group leader for Gastrointestinal Cancers for the Mayo Clinic Comprehensive Cancer Center in Phoenix, Arizona.In our exclusive interview, Dr Bekaii-Saab discussed findings from the final analysis of cohort 3 of the phase 3 BREAKWATER trial (NCT04607421), which were presented at the 2026 ASCO Annual Meeting. These data showed that encorafenib (Braftovi) plus cetuximab (Erbitux) and FOLFIRI (leucovorin, 5-fluorouracil, and irinotecan) significantly improved outcomes compared with standard of care in patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC), building on previously reported data from the trial that led to the February 2026 full FDA approval of encorafenib plus cetuximab and modified FOLFOX6 (leucovorin calcium, fluorouracil, and oxaliplatin) for this patient population. He also highlighted promising bispecific agents targeting VEGF and PD-1, as well as the promise of KRAS G12C inhibitors like calderasib (MK-1084) and sotorasib (Lumakras). Finally, he emphasized that minimal residual disease testing is prognostic and potentially predictive, and can aid in personalized mCRC management.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into an array of groundbreaking advancements and strategic movements reshaping the landscape of healthcare and medicine. Recent strides in Alzheimer's research have highlighted Biogen's promising Phase 2 clinical trial results for diranersen, an antisense oligonucleotide targeting the tau protein. Unlike traditional amyloid-targeting therapies, this approach offers a novel mechanism that could diversify treatment options for Alzheimer's patients. By addressing tau pathology, a critical feature of Alzheimer's disease, Biogen's findings may influence research trajectories and potentially lead to improved patient outcomes. In tandem with this, Biogen and Eisai have received FDA approval for a subcutaneous formulation of Leqembi (lecanemab), targeting amyloid-beta plaques. This new delivery method is poised to enhance patient compliance and accessibility, marking significant progress in broadening Alzheimer's treatment modalities. In oncology, AstraZeneca has entered into a substantial $1.5 billion licensing agreement with Dizal Pharmaceutical for lung cancer therapies. This strategic partnership emphasizes the importance of collaborative efforts in advancing cancer treatment and highlights the role of targeted therapies in addressing unmet medical needs. Additionally, Merck KGaA's Erbitux has secured European Commission approval for first-line treatment of BRAF V600E-mutant metastatic colorectal cancer. By focusing on specific genetic mutations, this approval illustrates the shift towards precision medicine, where treatments are tailored based on individual genetic profiles. The industry is also embracing advanced technologies such as artificial intelligence (AI) to enhance drug discovery processes. Chai Discovery's partnership with Novartis exemplifies this trend, as they focus on AI-driven therapeutic antibody discovery. Meanwhile, Ardigen and Veraxa Biotech's collaboration in optimizing T-cell engager and ADC drug discovery demonstrates AI's growing role in reducing timeframes and costs associated with bringing new therapies to market. Regulatory updates from the FDA seek to streamline registration rules to alleviate manufacturing burdens for biopharma companies, reflecting ongoing efforts to improve operational efficiencies in drug production. Additionally, new guidance on psychedelics indicates a regulatory openness that could stimulate innovation within neurological therapeutics. In other news, HUYABIO's Phase 3 trial results have shown promise for advanced skin cancer patients through a combination therapy involving Bristol Myers Squibb's Opdivo. This success underscores the potential of combination therapies to enhance treatment efficacy. Meanwhile, cell therapy is experiencing a transformative shift with Cellares' advancements in automating manufacturing processes. These innovations promise broader access to life-saving cell therapies by accelerating production timelines and reducing costs. Turning to business developments, Spero Therapeutics' $1.1 billion deal with Innovent Biologics marks a strategic pivot towards immune modulation therapies, highlighting the growing interest in autoimmune diseases. Concurrently, Avere Therapeutics' public listing via a reverse merger with NextCure and acquisition of an IL-23 drug signifies ongoing consolidation within the sector. On the regulatory front, Beckman Coulter's expansion of its Alzheimer's diagnostic portfolio through a CE mark for its p-tau217 assay enhances diagnostic capabilities crucial for early detection and management amid an aging global population. As we look globally, cities like Basel and Beijing are emerging as biotech hubs, attracting top talent and investments while fostering innovation. Amid these shifts, industry professionals are encouraged to adapt to evolving technological landscapes, particularly with AI poised to enhance decision-making processes and streamline clinical workflows. These developments illustrate a dynamic phase for pharma and biotech sectors where scientific breakthroughs are closely intertwined with strategic business decisions and regulatory advancements. As we continue to navigate these changes, the potential for delivering more effective treatments across various therapeutic areas is immense. Stay tuned as we bring you more insights into how these innovations are shaping the future of healthcare globally. Thank you for joining us at Pharma Daily; until next time.Support the show
Welcome to OncLive On Air®! I'm your host today, Courtney Flaherty.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, Michael J. Pishvaian, MD, PhD, sat down to discuss the evolving role of biomarker-directed strategies in gastrointestinal (GI) oncology, as well as the importance of early comprehensive testing to identify molecular drivers and resistance mechanisms when approaching frontline treatment selection and sequencing. Pishvaian serves as director of the Gastrointestinal, Developmental Therapeutics, and Clinical Research Programs for the Johns Hopkins Kimmel Cancer Center in the National Capital Region.Pishvaian began the discussion by highlighting the shift from a disease-site-specific approach to a molecularly defined paradigm, noting that microsatellite instability–high status and NTRK fusions now dictate therapy regardless of tumor origin. He reviewed the transformational data from the phase 3 HERIZON-GE-01 trial (NCT04276493), positing that zanidatamab (Ziihera) could become the new standard of care for HER2-positive upper GI cancers due to unprecedented survival outcomes. He also emphasized the emergence of Claudin 18.2-directed therapies, noting that data from the phase 2 ILUSTRO study (NCT03505320) demonstrates remarkable progression-free survival when adding zolbetuximab (Vyloy) to mFOLFOX6 and nivolumab (Opdivo) for high-expressing subgroups.The conversation then shifted to colorectal cancer, where Dr. Pishvaian detailed how data from the phase 3 BREAKWATER trial (NCT03845036) has "locked in" a paradigm requiring frontline testing for BRAF V600E mutations to guide the use of encorafenib (Braftovi) plus cetuximab (Erbitux). He also discussed the "care revolution" in KRAS inhibition, spotlighting the significant survival benefits seen with daraxonrasib in pancreatic cancer and the potential for novel allele-specific inhibitors to combat disease resistance.Finally, Pishvaian addressed the practicalities of implementation, noting that testing rates in the community remain low. He advocated for prioritizing testing, including liquid biopsies and ctDNA, at the time of initial diagnosis to ensure no patient is left behind.This content is a production of OncLive; this OncLive On Air podcast episode is supported by funding, however, content is produced and independently developed by OncLive.
We love to hear from our listeners. Send us a message. For all the drug commercialization successes he's played a leading hand in during his tenures at GSK, Genentech, and ImClone—Androderm, Augmentin, necitumumab, and Erbitux among them—Michael Bailey concedes that he's likely better known for his failures. After hearing his stories on this episode of the Business of Biotech, I tend to disagree. While he offers a transparent and instructive look at the failures themselves, I'd contend it's what he's done with those setbacks that defines his biopharma and biotech leadership legacy. Today, Bailey is CEO at Aveo Oncology, a company that saw its own set of challenges during the clinical development of now-commercial FOTIVDA (tivozanib) and ficlatuzumab. Tune in for Bailey's straight-shooting insight on how to turn biotech setbacks on their ear. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: matt.pillar@lifescienceconnect.comFind Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/
A new dosing regimen approved by the FDA on April 6, 2021 exceeds the current MUE if administered to a patient with a BSA of 3 m2. Pharmacy Revenue Cycle requested an increase which the NCCIPTP Coordinator has indicated will be implemented in a future quarterly update.
FDA Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)
Listen to a soundcast of April 6th & 7th FDA approvals of Erbitux (cetuximab) for K-Ras wild type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck and Trodelvy (sacituzumab govitecan) for unresectable locally advanced or metastatic triple negative breast cancer.
Here are the links for everything discussed in Episode 29, I'm also including times here so feel free to skip ahead to the topics that interest you. (1:15) FDA approval Koselugo (6:20) Reblozyl gets an added indication (8:35) Braftovi plus Erbitux for BRAFV600E mCRC (11:20) Nationwide recall of ranitidine (14:35) CDC updates on COVID-19 & influenza reporting Connect with The Rx Daily Dose:Twitter Instagram YouTube Linkedin WebsiteEmail: therxdailydose@gmail.comConnect with Ian Parnigoni PharmD. on social media:Twitter Instagram Linkedin ★ Support this podcast on Patreon ★
Dr. Nathan Pennell, Cleveland Clinic, describes other options for treatment of acquired resistance, including chemotherapy, ablation with SBRT and a combination of Gilotrif and Erbitux.
Dr. Nathan Pennell, Cleveland Clinic, describes other options for treatment of acquired resistance, including chemotherapy, ablation with SBRT and a combination of Gilotrif and Erbitux.
Dr. Nathan Pennell, Cleveland Clinic, describes other options for treatment of acquired resistance, including chemotherapy, ablation with SBRT and a combination of Gilotrif and Erbitux.
Drs. Jack West and Greg Riely field questions about which treatments should EGFR lung cancer patients consider when their cancers progress.
Drs. Jack West and Greg Riely field questions about which treatments should EGFR lung cancer patients consider when their cancers progress.
Drs. Jack West and Greg Riely field questions about which treatments should EGFR lung cancer patients consider when their cancers progress.
Dr. Jack West suggests that progression in T790M-negative EGFR lung cancer patients may not require a change in therapy. In this video he details what should go into the decision to modify treatment for those patients.
Dr. Jack West suggests that progression in T790M-negative EGFR lung cancer patients may not require a change in therapy. In this video he details what should go into the decision to modify treatment for those patients.
Dr. Jack West suggests that progression in T790M-negative EGFR lung cancer patients may not require a change in therapy. In this video he details what should go into the decision to modify treatment for those patients.
Immunotherapy Forum Video #28: Doctors are still weighing the pros and cons of giving a cancer patient immunotherapy before or after resection surgery. In part 1 of 2 videos, Dr. Jason Luke details those risks and benefits.
Immunotherapy Forum Video #28: Doctors are still weighing the pros and cons of giving a cancer patient immunotherapy before or after resection surgery. In part 1 of 2 videos, Dr. Jason Luke details those risks and benefits.
Immunotherapy Forum Video #28: Doctors are still weighing the pros and cons of giving a cancer patient immunotherapy before or after resection surgery. In part 1 of 2 videos, Dr. Jason Luke details those risks and benefits.
Today in FirstWord:
GRACE, cancerGRACE, GRACEcast, Jared Weiss, Unveristy of North Carolina-Chapel Hill, UNC-Chapel Hill, induction therapy, neoadjuvant therapy, head and neck cancer, HNSCC, carbplatin, paclitaxel, cetuximab, Taxol, Erbitux, weekly
GRACE, cancerGRACE, GRACEcast, Jared Weiss, Unveristy of North Carolina-Chapel Hill, UNC-Chapel Hill, induction therapy, neoadjuvant therapy, head and neck cancer, HNSCC, carbplatin, paclitaxel, cetuximab, Taxol, Erbitux, weekly
GRACE, cancerGRACE, GRACEcast, Jared Weiss, Unveristy of North Carolina-Chapel Hill, UNC-Chapel Hill, induction therapy, neoadjuvant therapy, head and neck cancer, HNSCC, carbplatin, paclitaxel, cetuximab, Taxol, Erbitux, weekly
Dr. Jared Weiss from the University of North Carolina, reviews several options as induction therapy for head and neck cancer and focuses on the potential appeal and tolerability of the combination of weekly carboplatin and paclitaxel with cetuximab.
Dr. Jared Weiss from the University of North Carolina, reviews several options as induction therapy for head and neck cancer and focuses on the potential appeal and tolerability of the combination of weekly carboplatin and paclitaxel with cetuximab.
Dr. Jared Weiss from the University of North Carolina, reviews several options as induction therapy for head and neck cancer and focuses on the potential appeal and tolerability of the combination of weekly carboplatin and paclitaxel with cetuximab.
Dr. Jared Weiss from the University of North Carolina, reviews several options as induction therapy for head and neck cancer and focuses on the potential appeal and tolerability of the combination of weekly carboplatin and paclitaxel with cetuximab.
Dr. Jared Weiss from the University of North Carolina, reviews several options as induction therapy for head and neck cancer and focuses on the potential appeal and tolerability of the combination of weekly carboplatin and paclitaxel with cetuximab.
Dr. Jared Weiss from the University of North Carolina, reviews several options as induction therapy for head and neck cancer and focuses on the potential appeal and tolerability of the combination of weekly carboplatin and paclitaxel with cetuximab.
Dr. Jared Weiss, Medical Oncologist at UNC-Chapel Hill, reviews lung cancer highlights in 2011, focusing here on treatments focusing on the EGFR axis.
Dr. Jared Weiss, Medical Oncologist at UNC-Chapel Hill, reviews lung cancer highlights in 2011, focusing here on treatments focusing on the EGFR axis.