Checkpoint Therapeutics : FDA to Review Application for Skin Cancer Therapy

 Checkpoint Therapeutics Inc. on Thursday said the U.S. Food and Drug Administration accepted for review its application seeking approval of its lead drug candidate cosibelimab in certain patients with the second most common type of skin cancer in the U.S.

The Waltham, Mass., said the application covers cosibelimab as a treatment for patients with metastatic cutaneous squamous cell carcinoma or locally advanced cSCC who aren't candidates for curative surgery or radiation.

Checkpoint said the FDA set a target action date of Jan. 3, 2024, for the application, adding that the agency has indicated that it doesn't currently plan to hold an advisory-committee meeting.

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