INDIANAPOLIS (dpa-AFX) - Eli Lilly and Company (LLY) announced the FDA has issued a complete response letter for the Biologics License Application for the investigational medicine sintilimab injection, a PD-1 inhibitor in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer. The CRL includes a recommendation for an additional clinical study, specifically a multiregional clinical trial.
Sintilimab is being developed by Innovent Biologics, Inc. and Lilly. The companies said they are assessing next steps for the sintilimab program in the U.S.
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