FDA to Reassess Use of PD-1 Inhibitors in Stomach Cancer, Seeking Expert Input on Merck, BMS, and BeiGene Medications

FDA Meeting:
The FDA has scheduled a meeting with the Oncologic Drugs Advisory Committee (ODAC) on September 26, 2024, to discuss the use of PD-1 inhibitors in stomach cancers, specifically focusing on PD-L1 expression levels as a predictive biomarker for treatment efficacy.

Drugs Under Review:
The discussion will include approved treatments such as Merck's Keytruda (pembrolizumab), Bristol Myers Squibb's Opdivo (nivolumab) and Yervoy (ipilimumab), and a new application for BeiGene's Tevimbra (tislelizumab).

PD-L1 Expression:
The FDA is considering whether approvals for these drugs should be restricted based on PD-L1 expression levels in tumors, as recent studies suggest better outcomes in patients with PD-L1 positive tumors.

Clinical Trials:
Clinical trials have used different methods to assess PD-L1 expression and define positivity, leading to a need for clarification and potential harmonization of PD-L1 recommendations.

Impact on Treatment:
The outcome of the meeting could lead to changes in the labeling and use of these drugs, potentially limiting their approval to patients with specific PD-L1 expression levels.