FDA approves cosibelimab-ipdl for advanced skin cancer
The agency cleared the PD-L1 blocking antibody for metastatic or locally advanced cutaneous squamous cell carcinoma on December 13, 2024.
On December 13, 2024, the FDA approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC).1
The FDA's announcement identifies cosibelimab-ipdl as a PD-L1 blocking antibody and names Checkpoint Therapeutics, Inc. as the sponsor associated with the product, marketed under the brand name Unloxcyt.
The approval applies to adult patients with either the metastatic or locally advanced form of cutaneous squamous cell carcinoma. The FDA's statement does not provide additional detail on trial results, dosing, or efficacy data in this announcement.
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