Sun Pharmaceutical Industries Limited (Sun Pharma) said the National Comprehensive Cancer Network (NCCN) gave UNLOXCYT a Category 2A recommendation for locally advanced skin cancer, a designation that may inform U.S. coverage decisions.
According to the Oct. 20 announcement, the recommendation applies to locally advanced cutaneous squamous cell carcinoma when surgery and radiation cannot cure the disease. Sun Pharma said the new listing follows a Category 2A designation for metastatic disease in 2025.
The U.S. Food and Drug Administration (FDA) had already approved cosibelimab-ipdl on Dec. 13, 2024. Its authorization covers adults with metastatic or locally advanced cutaneous squamous cell carcinoma when curative surgery or curative radiation is not an option. The agency describes the medicine as an antibody that blocks programmed death ligand-1 (PD-L1).
In the locally advanced group of Study CK-301-101, 17 of 31 patients had an objective response, a rate of 55%, FDA prescribing information shows. Eight patients, or 26%, had a complete response. After a median follow-up of 24.1 months, the median duration of response had not been reached.
Those figures appear in the FDA label revised in August 2026. The authors of the published study identified its nonrandomized design and limited biomarker analysis as limitations.
Patients in the locally advanced group received 800 mg every two weeks. The FDA-recommended regimen is 1,200 mg by intravenous infusion over 60 minutes every three weeks. The label warns that reactions involving the immune system can be severe or fatal. It lists fatigue, musculoskeletal pain, rash and diarrhea among common adverse reactions.
Sun Pharma said NCCN guidance informs payer coverage policies, prior-authorization criteria and institutional formularies, which can affect patient access. Its announcement identified no new coverage decision or price.
