*February 2022*
The FDA’s Oncologic Drugs Advisory Committee voted against using single-country foreign data to support a biologics license application (BLA) for sintilimab injection plus pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with nonsquamous non–small cell lung cancer (NSCLC).
ODAC concluded that supporting data from the phase 3 ORIENT-11 trial (NCT03607539), conducted entirely in China, could not be applied to the US population. Read more.
