Checkpoint's antibody therapy for skin cancer gets FDA review
Iryna Drozd
- The U.S. Food and Drug Administration (FDA) accepted for review Checkpoint Therapeutics' (NASDAQ:CKPT) application seeking approval of cosibelimab to treat patients with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not eligible for curative surgery or radiation.
- The FDA is expected to make a decision on the biologics license application (BLA) by Jan. 3, 2024.
- Checkpoint noted that the FDA indicated that the agency does not currently plan to hold an advisory committee meeting to discuss the filing.
- The BLA was backed by data from a trial evaluating the anti-PD-L1 antibody cosibelimab in patients with metastatic and locally advanced cSCC, a type of skin cancer.
- "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," said Checkpoint President and CEO James Oliviero.
- CKPT -0.41% to $4.90 premarket March 2.