Checkpoint Therapeutics, Inc. announced that the U.S. Food and Drug Administration (?FDA?) has issued a complete response letter (?CRL?) for the cosibelimab biologic license application (?BLA?) for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (?cSCC?) who are not candidates for curative surgery or radiation. The CRL only cites findings that arose during a multi-sponsor inspection of Checkpoint?s third-party contract manufacturing organization as approvability issues to address in a resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.
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- U.S. Food and Drug Administration Issues Complete Response Letter for Checkpoint Therapeutics, Inc.'s Cosibelimab Solely Due to Inspection Findings At Third-Party Manufacturer