Sun‍‌‍‍‌‍‌‍‍‌ Pharma Secures FDA Approval for Long-Term UNLOXCYT Label after Successful Clinical Outcomes

Mumbai, November 26, 2025: Sun Pharma, an Indian pharmaceutical giant, announced that the U.S. Food & Drug Administration (FDA); has approved a new label for UNLOXCYTTM (cosibelimab-ipdl) based on long-term solid data from the pivotal CK-301-101 clinical study. The drug is thus positioned with this new label as a first-line therapy for aCSCC, i.e., mCSCC and laCSCC cases where surgery or radiation is not feasible.

Revised Label Reflects the Representative Clinical Effects Over Time

The expanded dataset of 109 patients showed that more than half achieved an objective response. Among them, complete response rates stood at 13% for mCSCC and 26% for laCSCC, while partial responses were recorded at 37% and 29%, respectively. Notably, the median duration of response has not yet been reached for either group, underscoring sustained clinical benefit—67% of responders in mCSCC and 88% in laCSCC maintained their response for at least 12 months. The treatment also demonstrated early efficacy, with a median time to response of 1.9 months for metastatic cases and 3.6 months for locally advanced cases.

There were no significant changes in the safety profile compared to the previous one. The immune-mediated adverse events reported were in line with those previously reported: fatigue, musculoskeletal pain, rash, and gastrointestinal symptoms. No unfortunate events related to treatment occurred during the study.

Management & Expert Point of View on the Approval

Sun Pharma North America CEO Richard Ascroft considered that the expanded data set is “An evolution in checkpoint inhibition” and hence supports UNLOXCYT as “an evolution in checkpoint inhibition” for a CSCC.

Dr. Emily Ruiz from Harvard Medical School, who conducted the long-term study, also observed that durable responses with good tolerability are highly valuable, particularly in elderly patients with multiple comorbidities, thus giving a high-need population a much-needed solution.

With this approval, Sun Pharma plans to launch UNLOXCYT in the market in early 2026. Thanks to a more solid clinical foundation, the drug that was first approved in 2024 will finally be able to play its full role within the Sun Pharma oncology portfolio.

Context: Unmet Need in aCSCC Treatment Landscape

Cutaneous squamous cell carcinoma is counted among the top three most common skin cancers in the world. While the early stage is controllable, either with surgery or radiation, a fairly large number of cases, i.e., approximately 40,000 annually in the U.S.-turn to the advanced stage, of which about 15,000 result in death every year. The advanced patients normally have very few drugs available and a bleak prognosis. The new label for UNLOXCYCT is a welcome move in the fight against advanced cancer, as it offers this group of patients a more durable and tolerable therapy.

Stock Performance – Market Reaction to News

The share price of Sun Pharma was trading at ₹1,792.00, up 0.86% as of 10:48 am IST. The stock now sits comfortably below its 52-week high of ₹1,910 and well above its 52-week low of ₹1,548. Following the announcement, the counter saw noticeable activity as investors factored in the long-term value emerging from the updated UNLOXCYT clinical data.

REF: https://nsearchives.nseindia.com/corporate/SUNSEC_26112025085357_SE_IntimationPR.pdf

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