Checkpoint Therapeutics Gets CRL Due to Third-Party Manufacturer Inspection

Checkpoint Therapeutics announced that the FDA has issued a complete response letter (CRL) for its cosibelimab BLA based on an inspection of the company’s third-party manufacturer, with no issues cited on the approvability of the drug itself.

The CRL cites observations from an inspection of Checkpoint’s third-party contract manufacturing organization as issues to address in a resubmission, according to Checkpoint. The CRL did not “state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab,” the company said.

The FDA had accepted the Checkpoint BLA for cosibelimab in March and set a PDUFA date of Jan. 4, 2024.

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