The US Food and Drug Administration (FDA) has rejected the biologics license application (BLA) of Eli Lilly and Company (Lilly)’s sintilimab injection in nonsquamous non-small cell lung cancer (NSCLC).
Lilly has been issued a complete response letter (CRL) for the BLA for the PD-1 inhibitor in combination with pemetrexed and platinum chemotherapy. The US pharma giant is seeking approval for the combination for the first-line treatment of people with NSCLC.
According to Lilly, the CRL suggests that the review cycle is over but the FDA is not able to approve the BLA in its present form in line with the outcome of the Oncologic Drugs Advisory Committee Meeting in February 2022.
The CRL recommends an additional clinical study, particularly a multiregional clinical trial to compare the standard of care therapy for first line metastatic NSCLC to sintilimab with chemotherapy using a non-inferiority design with an overall survival endpoint.
Sintilimab is being developed by Lilly alongside Innovent Biologics. The two firms will assess the next steps for the PD-1 inhibitor in the US.
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