Checkpoint Therapeutics Gets FDA Response Letter on Cosibelimab Application
By Dean Seal
Checkpoint Therapeutics intends to resubmit a biologic license application for cosibelimab, its treatment for a type of skin cancer, after federal regulators issued a complete response letter to its first application.
The Waltham, Mass.-based company said the Food and Drug Administration's letter, which indicates that the agency can't approve the application in its current form, cites findings that arose during a multi-sponsor inspection of Checkpoint's third-party contract manufacturer.
The letter didn't state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab, Checkpoint said. Cosibelimab is designed to treat patients with metastatic or locally advanced cutaneous squamous cell carcinoma who aren't candidates for surgery or radiation.
Chief Executive James Oliviero said the company should be able to address the feedback in a resubmission, with the goal of getting marketing approval for cosibelimab next year.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
December 18, 2023 07:44 ET (12:44 GMT)
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