Unloxcyt FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 16, 2024.
FDA Approved: Yes (First approved December 13, 2024)
Brand name: Unloxcyt
Generic name: cosibelimab-ipdl
Dosage form: Injection
Company: Checkpoint Therapeutics, Inc.
Treatment for: Squamous Cell Carcinoma
Unloxcyt (cosibelimab-ipdl) is a programmed death ligand-1 (PD-L1) blocking antibody used for the treatment of cutaneous squamous cell carcinoma.
- 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.
- Cutaneous squamous cell carcinoma is a type of skin cancer that begins in cells that form the epidermis. It can cause significant functional morbidities and cosmetic deformities, and has the potential to develop into a life-threatening disease.
- Unloxcyt is a fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Unloxcyt works by removing the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response.
- FDA approval for Unloxcyt was based on clinically meaningful objective response rate (ORR) and duration of response (DOR) data from Study CK-301-101.
- Unloxcyt is administered by intravenous infusion over 60 minutes every 3 weeks.
- Warnings and precautions associated with Unloxcyt include immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
- Common adverse reactions (≥10%) include fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.
Development timeline for Unloxcyt
Further information
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