The U.S. Food and Drug Administration (FDA) has accepted for review Checkpoint’s resubmission of its Biologics License Application (BLA) for cosibelimab, its anti-programmed death ligand-1 (PD-L1) antibody, as a potential new treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or curative radiation.
The resubmission has been accepted as a complete response to the FDA’s December 2023 complete response letter (CRL) and the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.
In December 2023, the FDA issued a CRL for the cosibelimab BLA, which only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization (CMO) as approvability issues to address in a BLA resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.
