By VETTAPHARMA reporter: Sun Pharmaceutical Industries Limited announced the commercial availability of UNLOXCYT
(cosibelimab-ipdl) in the United States, marking a significant expansion of its oncology portfolio. The company said UNLOXCYT is now available for healthcare professionals to prescribe for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not candidates for curative surgery or curative radiation, according to a press release.
UNLOXCYTTM is described in the release as an evolution in checkpoint inhibition, now incorporating long-term clinical data demonstrating durable efficacy and a proven tolerability profile. The U.S. Food and Drug Administration (FDA) recently approved an updated label for the drug that reflects long-term follow-up data from the pivotal CK-301-101 clinical trial.
The CK-301-101 study showed that at least 50% of patients experienced an objective response (complete or partial response), including higher rates of disease control among patients with stable disease. Many patients in the trial achieved durable responses, and the median duration of response had not yet been reached in either treatment group at the time of analysis, the company said.
In the press release, Ann W. Silk, MD, MS, medical oncologist at Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School, highlighted that UNLOXCYT offers a new treatment option for patients with unresectable or metastatic CSCC, particularly those who tend to be older and have multiple comorbidities.
Richard Ascroft, CEO of Sun Pharma North America, emphasized the company’s commitment to ensuring access to the new therapy from day one and noted the importance of the accompanying UNLOXCYT SUPPORT
patient access and affordability program to help healthcare professionals and patients throughout their treatment journey.
UNLOXCYT is available through a limited distribution network of authorized specialty distributors and one contracted specialty pharmacy. Sun Pharma’s announcement underscores its strategy to extend differentiated immunotherapy treatment options within its growing cutaneous oncology portfolio.
Source credit:
Sun Pharmaceutical Industries Limited. (2026, January 15). Sun Pharma announces the availability of UNLOXCYT
(cosibelimab-ipdl) for advanced cutaneous squamous cell carcinoma (aCSCC) [Press release]. Click here
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