Checkpoint Therapeutics Reaches BLA Alignment With FDA for Cosibelimab

By Chris Wack

Checkpoint Therapeutics said it has reached alignment with the Food and Drug Administration on its biologics license application resubmission strategy for its cosibelimab cancer treatment.

The oncology company said Monday it plans to move forward with a mid-year BLA resubmission seeking the U.S. marketing approval for cosibelimab. This is a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma who aren't candidates for curative surgery or curative radiation.

In December 2023, the FDA issued a complete response letter for the cosibelimab BLA, which only cited findings that arose during a multi-sponsor inspection of Checkpoint's third-party contract manufacturing organization as approvability issues to address in a BLA resubmission.

The letter didn't state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

06-24-24 0801ET