The US Food and Drug Administration’s Oncologic Drugs Advisory Committee overwhelmingly agreed that first-line indications for PD-1 inhibitors in HER2-negative, microsatellite-stable gastric and gastroesophageal junction (GEJ) adenocarcinoma and esophageal squamous cell carcinoma should be revised to add a threshold level of PD-L1 expression despite misgivings about the variability of biomarker measurement.
All Comers No More? US FDA AdComm Supports PD-L1 Threshold In Esophageal, Gastric Cancer
Maturing data supporting first-line indications for Merck’s Keytruda, Bristol’s Opdivo and BeiGene’s Tevimbra show inadequate efficacy for patients at the lowest level of PD-L1 expression in esophageal and gastric cancers.
More from US FDA Performance Tracker
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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
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The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
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The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.
More from US Advisory Committees
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The February meeting of US CDC’s Advisory Committee on Immunization Practices was indefinitely delayed to accommodate public comment, which did not open as scheduled on 3 February.
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Pink Sheet editors and special guest Michael McCaughan of Prevision Policy discuss Robert F. Kennedy Jr.’s first act as HHS Secretary, former FDA Commissioner Scott Gottlieb’s suggestion that industry extend the existing user fee agreement rather than negotiate a new one, and President Trump’s policies impacting FDA advisory committee schedules and staffing.
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HHS communications restrictions are keeping the FDA from publicly scheduling expected advisory committee meetings. The lack of upcoming meetings is raising concern about missed user fee dates or lower-quality agency decision-making.