Checkpoint Therapeutics Announces FDA Filing Acceptance of Biologics License Application for ...
Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing the Biologics License Application (“BLA”) for cosibelimab, Checkpoint’s investigational anti-PD-L1 antibody, as a treatment for patients with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or radiation
Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024
FDA indicates that it does not currently plan to hold an advisory committee meeting
WALTHAM, Mass., March 02, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing the Biologics License Application (“BLA”) for cosibelimab, Checkpoint’s investigational anti-PD-L1 antibody, as a treatment for patients with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or radiation. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024. In its BLA filing acceptance letter, 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 filing acceptance of our BLA is a major milestone for Checkpoint and our promising cosibelimab development program,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “We look forward to continuing to work closely with the FDA as we endeavor to bring cosibelimab to patients in need as quickly as possible. I would like to thank the patients and physicians who participated in the cosibelimab clinical studies, as well as our team for their hard work and dedication in achieving this important milestone.”
Mr. Oliviero continued, “According to U.S. prescription claims data, in 2021, approximately 11,000 cSCC patients were treated with systemic therapies. As PD-1 inhibitors comprised less than half of patient prescriptions, cSCC remains a disease with a high need for more effective and tolerable treatment options, particularly for the significant number of cSCC patients with immunosuppressive conditions or autoimmune diseases. With its unique mechanism of action and compelling safety profile, we believe cosibelimab, if approved, would be uniquely positioned to provide an important new treatment option for cSCC patients that are currently underserved by available therapies.”
