News Briefs: FDA Revises Keytruda, Opdivo GI Indications

Jun 12
Jun 12, 2025

The FDA has revised prescribing labels for two programmed death receptor-1 (PD-1) inhibitors to narrow their gastrointestinal indications to programmed death ligand-1 (PD-L1)-positive disease. In May 22 letters, the agency confirmed the changes to Merck & Co., Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab). The moves follows a Sept. 26, 2024, Oncology Drug Advisory Committee (ODAC) meeting on the use of immune checkpoint inhibitors in people with unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Committee members voted 10-2, with one abstention, that the risk benefit assessment for using PD-1 inhibitors in first-line advanced HER2-negative microsatellite stable gastric/GEJ adenocarcinoma in people with PD-L1 expression <1 was not favorable. They also voted 11-1 that the risk benefit assessment for using PD-1 inhibitors in first-line unresectable or metastatic esophageal squamous cell carcinoma with PD-L1 expression <1 was not favorable.
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Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.