FDA Launches Review of PD-1 Inhibitor from Chinese Drugmaker

The FDA has begun its review of Innovent Biologics’ and Eli Lilly’s biologics license application for sintilimab, a PD-1 inhibitor for the first-line treatment of nonsquamous nonsmall-cell lung cancer (NSCLC) alongside chemotherapy.

Innovent, based in Suzhou, China, would become the first Chinese drugmaker to receive approval from the FDA for a PD-1 inhibitor if the agency gives a greenlight for the treatment. An approval would put the drug in the same category as blockbusters such as Merck’s Keytruda (pembrolizumab), Bristol Myers Squibb’s Opdivo (nivolumab) and Regeneron’s Libtayo (cemiplimab).

Innovent and Eli Lilly, which are developing and commercializing the drug under a global collaboration agreement, are seeking approval of the drug as a first-line treatment of NSCLC in combination with pemetrexed and platinum chemotherapy.

The application is supported mainly by positive phase 3 trial findings and the agency has set a target decision date for the drug in March 2022. The trial’s primary analysis population of 280 patients showed a statistically significant improvement in overall survival compared to docetaxel, meeting the primary endpoint.