8.22.2024 FDA weighs limiting PD-1 drugs in stomach cancer, calls on experts to discuss Merck, BMS and BeiGene meds

The FDA is once again gathering external experts to scrutinize PD-1 inhibitors as a group. This time, the agency is considering limiting these immunotherapies’ use in stomach cancer and esophageal cancer.

The FDA will hold an Oncologic Drugs Advisory Committee (ODAC) meeting Sept. 26 to consider whether approvals for checkpoint inhibitors in advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma—as well as in esophageal squamous cell carcinoma (ESCC)—should be restricted based on tumors’ PD-L1 expression, the agency said in a public filing (PDF)