Experts support FDA's plan for restrictions on PD-1 drugs in stomach, esophageal cancers

Experts support FDA's plan for restrictions on PD-1 drugs in stomach, esophageal cancers

Source: 
Fierce Pharma
snippet: 

The days of broad approvals for PD-1 inhibitors in stomach and esophageal cancers appear to be numbered.

A group of external advisers to the FDA voted 10-2 that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer is not favorable in patients who have PD-L1-negative tumors, as measured by a combined positive score (CPS) or tumor area positivity (TAP) score below 1. One additional expert abstained.