Checkpoint Therapeutics shared that the U.S. FDA has declined to approve its anti-PD-L1 antibody due entirely to inspection issues at the third-party contract manufacturing site.
The agency issued a complete response letter for the cosibelimab 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. But according to Massachusetts-based Checkpoint, the CRL only cites findings that arose during a multi-sponsor inspection of Checkpoint’s CMO, and no concerns about the clinical data package, safety or labeling.
The bad news came slightly ahead of schedule — the FDA accepted Checkpoint's BLA back in March, assigning a PDUFA date of January 3, 2024.
Cosibelimab is designed as a more effective and tolerable treatment option for cSCC, the second most common type of skin cancer in the U.S. According to Checkpoint, cosibelimab delivers a "powerful one-two punch to eradicate tumors," by binding to PD-L1 with sustained high target tumor occupancy to reactivate the body’s T-cell anti-tumor response, with the addition of a functional Fc domain to activate the body’s natural killer immune cells to induce cell-mediated cytotoxicity of tumor cells.
Given that the CRL was based solely on CMO issues, Checkpoint says it can address the feedback in a resubmission, enabling marketing approval in 2024.