Sun Pharmaceutical Industries Limited has announced that UNLOXCYT™ (cosibelimab-ipdl) is now available in the United States for prescription by healthcare professionals. The treatment is indicated for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not eligible for curative surgery or radiation therapy.
UNLOXCYT is an anti–PD-L1 monoclonal antibody designed to support antibody-dependent cellular cytotoxicity. The US Food and Drug Administration recently approved an updated label reflecting long-term follow-up data from the pivotal CK-301-101 clinical trial. The updated data showed improvements in objective response rates and duration of response, with no change to the previously reported safety profile.
In the clinical study, at least 50% of patients achieved an objective response, including complete or partial responses. Complete response rates were observed in both metastatic and locally advanced patient groups. Disease control, including stable disease, was achieved in 71% of treated patients, and median duration of response has not yet been reached.
The most commonly reported adverse reactions included fatigue, musculoskeletal pain, rash, diarrhoea and hypothyroidism. Immune-mediated adverse reactions were largely mild to moderate, with limited incidence of higher-grade events. UNLOXCYT is available through a limited distribution network of authorised specialty distributors and one contracted specialty pharmacy.
Sun Pharma stated that patient support services will be available through the UNLOXCYT SUPPORT™ programme to assist healthcare professionals and patients during treatment. Headquartered in India, Sun Pharma is the largest pharmaceutical company in the country and a leading generics player in the United States and other key markets.
The company’s product portfolio spans therapeutic areas including dermatology, oncology, ophthalmology, cardiology and neurology. Sun Pharma has built a growing innovative medicines pipeline, particularly in dermatology and onco-dermatology, alongside a broad range of generic formulations.
Its vertically integrated manufacturing network spans multiple continents, ensuring quality and supply reliability. Sun Pharma exports to more than 100 countries and serves patients through a combination of prescription and consumer health products, supported by research-driven development and global regulatory capabilities.
