Checkpoint Therapeutics, Inc. disclosed that the FDA issued a Complete Response Letter (CRL) in connection with the cosibelimab biologic license application (BLA) intended for the treatment of individuals with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not eligible for curative surgery or radiation. The CRL specifically attributes issues leading to non-approval to findings identified during a comprehensive inspection of Checkpoint's third-party contract manufacturing organization. It is noteworthy that the CRL does not express any concerns regarding the clinical data package, safety, or labeling related to the cosibelimab approval process.
James Oliviero, President and Chief Executive Officer of Checkpoint, expressed confidence in addressing the identified deficiencies through a resubmission, targeting marketing approval in 2024. He emphasized the commitment of Checkpoint to collaborate closely with the third-party manufacturer and the FDA throughout the resubmission process, with the ultimate goal of making cosibelimab accessible to patients grappling with cSCC.
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