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ODAC Recommends New Trial Data of Sintilimab in US Population of Frontline NSCLC

*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.