Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. The pair sought approval of a BLA for sintilimab plus pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small-cell lung cancer (NSCLC) but found near-unanimous opposition from FDA advisers dissatisfied with China-only trial data submitted in support of the application. The medicine is already approved for multiple indications in China, where it’s marketed as Tyvyt.