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# FDA Approves Checkpoint’s Unloxcyt
- URL: https://www.fdaweb.com/fda-approves-checkpoints-unloxcyt/
- Published: 2025-01-03T12:00:00.000Z
- Updated: 2026-09-14T14:49:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158375

FDA has approved Checkpoint Therapeutics’ Unloxcyt (cosibelimab-ipdl) for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. An agency [notice](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cosibelimab-ipdl-metastatic-or-locally-advanced-cutaneous-squamous-cell-carcinoma?ref=fdaweb.com) says efficacy was established in Study CK-301-101 in 109 patients. The major outcome measures were objective response rate and duration of response as assessed by an independent central review committee, the notice says.

The most common adverse reactions were reported to be fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, pruritus, edema, localized infection, and urinary tract infection.

FDA’s review used the company’s voluntarily submitted Assessment Aid.