Posted by Michael Wonder on 24 Mar 2022
Lilly announces complete response letter for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with non-squamous non-small cell lung cancer
24 March 2022 - Eli Lilly today announced that the U.S. 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 pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer.
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.
