Sun Pharma's UNLOXCYT Gets NCCN Category 2A Preferred Status for Advanced Skin Cancer
Mumbai: Sun Pharmaceutical Industries Ltd. has announced that its cancer drug UNLOXCYT (cosibelimab-ipdl) has received a Category 2A Preferred designation in the updated National Comprehensive Cancer Network (NCCN) guidelines for locally advanced cutaneous squamous cell carcinoma (laCSCC).
The recommendation applies to adults with locally advanced cutaneous squamous cell carcinoma who are not eligible for curative surgery or curative radiation. The latest designation expands UNLOXCYT’s existing NCCN Category 2A status for metastatic cutaneous squamous cell carcinoma, which was granted in 2025.
According to data from the pivotal registration study cited in the report, UNLOXCYT demonstrated an objective response rate of 55%, with 26% of patients achieving a complete response.
At a median follow-up of 24.1 months, the median duration of response had not yet been reached, with responses lasting from 8.3 months to more than 31.3 months.
The study also reported a low incidence of severe immune-mediated adverse reactions. Fewer than 1% of patients experienced Grade 3–5 immune-mediated adverse reactions, and no Grade 4 or Grade 5 reactions were reported.
UNLOXCYT is a PD-L1-blocking antibody approved by the US Food and Drug Administration (FDA) in 2024 for advanced cutaneous squamous cell carcinoma. Its approved use includes adults with metastatic or locally advanced disease who are not candidates for curative surgery or radiation.
The expanded NCCN recommendation adds locally advanced disease to the drug’s existing guideline recognition for metastatic disease. NCCN guidelines are widely used by oncology professionals and can influence treatment decisions, insurance coverage policies and institutional formularies.
Sun Pharma executives said the updated designation reflects the growing body of clinical evidence supporting the treatment and may help eligible patients access therapy.
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