Checkpoint Announces FDA Filing Acceptance Of BLA For Cosibelimab

(RTTNews) - Checkpoint Therapeutics, Inc. (CKPT) announced the FDA has accepted for filing the Biologics License Application for cosibelimab, an investigational anti-PD-L1 antibody, as a treatment for patients with metastatic cutaneous squamous cell carcinoma or locally advanced cSCC who are not candidates for curative surgery or radiation. The FDA has set a PDUFA goal date of January 3, 2024.

The FDA indicated that no potential filing review issues have been identified, and that an advisory committee meeting to discuss the application is not currently planned.

The company said its BLA submission is supported by the positive results from registration-enabling clinical trial evaluating cosibelimab in patients with metastatic and locally advanced cSCC.

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