FDA provides complete response to filing of sintilimab in non-small cell lung cancer.- Eli Lilly
Eli Lilly announced that the FDA has issued a complete response letter (CRL) for the Biologics License Application (BLA) for the investigational medicine sintilimab injection, a PD-1 inhibitor in combination with Alimta (pemetrexed) and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC).
The letter indicates that the review cycle is complete but the FDA is unable to approve the application in its current form, consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in February. The CRL includes a recommendation for an additional clinical study, specifically a multiregional clinical trial comparing standard of care therapy for first line metastatic NSCLC to sintilimab with chemotherapy utilizing a non-inferiority design with an overall survival endpoint.
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