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All Comers No More? US FDA AdComm Supports PD-L1 Threshold In Esophageal, Gastric Cancer

 
• By Bridget Silverman

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.

cancer cells
ODAC members considered PD-1 risk-benefit questions in two types of cancer. • Source: Shutterstock

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.

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More from US FDA Performance Tracker

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

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.

US FDA’s March Approval Candidates Take Aim At Established Markets

 
• By Bridget Silverman

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.

More from US Advisory Committees

US FDA Advisory Committee Meetings In Jeopardy After Layoffs, But Some Employees Called Back

 
• By Sue Sutter

Most, if not all, adcomm support staff in the drug and biologic centers who handled meeting-specific tasks have been laid off, although sponsors still are preparing for the public reviews. Meanwhile, some cut FDA employees are being called back to work for "continuity of operations activities."

Recent And Upcoming FDA Advisory Committee Meetings

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US CDC Vaccines AdComm Rescheduled For April Without Influenza Vote

 
• By Bridget Silverman and Sarah Karlin-Smith

The disruption of CDC’s Advisory Committee on Immunization Practices meeting schedule adds fuel to concerns about potential alterations of the vaccine schedule raised by former FDA Commissioner Scott Gottlieb.