India Pharma Outlook Team | Wednesday, 21 October 2026
Unloxcyt hits preferred status after Sun Pharma’s $355M acquisition strengthens its role in advanced skin cancer care.
The therapy now carries a National Comprehensive Cancer Network Category 2A recommended option for patients with locally advanced cutaneous squamous cell carcinoma who cannot undergo curative surgery or radiation.
This upgrade adds to the Category 2A designation for metastatic disease granted in 2025 and rests on solid pivotal trial results that show durable responses plus a favorable safety profile.
Sun Pharma advances its cutaneous oncology presence as clinicians gain confidence in this first-and-only FDA-approved PD-L1-blocking antibody for advanced CSCC.
The recognition further supports patient access by shaping payer policies and clinical pathways.
Sun Pharmaceutical Industries announces that Unloxcyt (cosibelimab-ipdl) rises to a National Comprehensive Cancer Network Category 2A recommended option for patients with locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation. This joins the Category 2A status already assigned for metastatic disease in 2025.
The U.S. Food and Drug Administration approved Unloxcyt in 2024 for adults with metastatic or locally advanced CSCC who cannot receive curative surgery or radiation. The recommended dose is 1,200 mg as an intravenous infusion over 60 minutes every three weeks. Unloxcyt remains the first and only FDA-approved PD-L1-blocking antibody for advanced CSCC.
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The pivotal registration study underpins the NCCN update. Fifty-five percent of patients achieve an objective response, and 26 percent achieve a complete response.
Responses last: at a median follow-up of 24.1 months, the median duration of response remains unreached, ranging from 8.3 to more than 31.3 months. Fewer than 1 percent of patients experience high-grade (Grade 3-5) immune-mediated adverse reactions, with no Grade 4 or 5 events reported.
Ahmad Naim, Senior Vice President and North American Chief Medical Officer at Sun Pharma, notes that the NCCN Guidelines guide physicians in choosing treatments across disease settings. He calls the Category 2A elevation an important milestone that validates the clinical evidence and shows growing expert confidence in Unloxcyt for this challenging disease.
Dr. Francis Worden of the University of Michigan Rogel Cancer Center states that the update reflects strong published evidence supporting Unloxcyt as first-line treatment for locally advanced disease. He points to the durable responses and low rate of high-grade immune-mediated adverse reactions, a key factor for mainly elderly patients who often face other health issues.
Sun Pharma secured Unloxcyt through its $355 million acquisition of Checkpoint Therapeutics last year. The PD-L1 inhibitor blocks the PD-L1 protein on tumor cells and boosts the immune system’s ability to detect and destroy cancer cells.
Cutaneous squamous cell carcinoma ranks among the most common skin cancers. An estimated 40,000 U.S. patients progress to advanced disease each year, leading to nearly 15,000 deaths. Tumors often appear in the head and neck and can invade vital structures.
Mark Gimbert, Senior Vice President and Head of Market and Patient Access for North America at Sun Pharma, stresses that many patients with locally advanced disease are older and medically complex.
Access to a therapy offering durable responses with a low rate of high-grade immune-mediated adverse reactions proves especially valuable. NCCN recognition helps appropriate patients receive treatment without unnecessary barriers.
Sun Pharma continues building on its long leadership in dermatology to advance care across the skin cancer continuum.
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