In Expected Decision, FDA Rejects Lilly's Sintilimab in NSCLC

The U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab. The biologics application was for the drug in combination with pemetrexed and platinum chemotherapy for first-line treatment for nonsquamous non-small cell lung cancer (NSCLC).