Cosibelimab FDA Approval Status

FDA Approved: No
Generic name: cosibelimab
Company: Checkpoint Therapeutics, Inc.
Treatment for: Squamous Cell Carcinoma

Cosibelimab is an anti-PD-L1 antibody in development for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma.

Cutaneous squamous cell carcinoma is a type of skin cancer that can cause significant functional morbidities and cosmetic deformities, and can develop into a potentially life-threatening disease.
Cosibelimab is a fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. Cosibelimab works to treat cutaneous squamous cell carcinoma by removing the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response.

Development timeline for cosibelimab

Date	Article
Dec 18, 2023	U.S. Food and Drug Administration Issues Complete Response Letter for Cosibelimab Solely Due to Inspection Findings at Third-Party Manufacturer
Jan 4, 2023	Checkpoint Therapeutics Submits Biologics License Application to FDA for Cosibelimab as a Treatment for Patients with Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

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