Posted by Michael Wonder on 18 Dec 2023
US FDA issues complete response letter for cosibelimab solely due to inspection findings at third party manufacturer
18 December 2023 - FDA did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.
Checkpoint Therapeutics today announced that the US FDA has issued a complete response letter for the cosibelimab biologic license application for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.
