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.

The US FDA Oncology Center of Excellence head also urged companies to commit to offer their PD-L1 drugs to certain patients free of charge via compassionate use if the gastric and esophageal cancer labeling is modified.

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors. 

The Oncologic Drugs Advisory Committee will discuss restrictions for patients expressing  PD-L1 in first-line labeling for Merck’s Keytruda, Bristol Myers Squibb’s Opdivo, and a pending NDA for BeiGene’s Tevimbra.