Treats metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC…. BLA 761297, held by Checkpoint Therapeutics Inc. Cosibelimab-Ipdl.
As of Nov 14, 2026, BLA 761297 (Unloxcyt), held by Checkpoint Therapeutics Inc, was first approved by FDA on Dec 13, 2024, with 2 approved supplements and 1 published complete response letter.
1. INDICATIONS AND USAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT is a programmed death ligand-1 (PD-L1) blocking antibody
| Nov 21, 2025 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Dec 13, 2024 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Dec 15, 2023 | Cosibelimab (CK-301)Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Unloxcyt300MG/5ML(60MG/ML) · injectable;injection | Cosibelimab-Ipdl | Rx |
| Aug 31, 2026 | Supplement 4Labeling · Standard review | Approved | |
| Nov 21, 2025 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Dec 13, 2024 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
