Sun Pharma’s UNLOXCYT receives NCCN Category 2A recommendation

Sun Pharmaceutical Industries announced that UNLOXCYT (cosibelimab-ipdl) has been designated as an NCCN Category 2A recommended option for patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) who are ineligible for curative surgery or radiation.

This update follows a previous Category 2A designation received in 2025 for metastatic cutaneous squamous cell carcinoma (mCSCC). UNLOXCYT, which was FDA-approved in 2024, is the first and only PD-L1-blocking antibody approved for advanced CSCC.

Clinical data from pivotal registration studies showed an objective response rate of 55% in laCSCC patients, including a 26% complete response rate. At a median follow-up of 24.1 months, the median duration of response had not yet been reached. Safety reports indicated that fewer than 1% of patients experienced grade 3 to 5 immune-mediated adverse reactions, with no grade 4 or 5 reactions reported.