Sun Pharma Unleashes UNLOXCYT: Skin Cancer's New Game-Changer Hits US Shelves

Sun Pharmaceutical Industries Limited has launched UNLOXCYT (cosibelimab-ipdl) in the US, marking a key advancement for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) ineligible for curative surgery or radiation. Backed by updated FDA label data from long-term trials, the drug promises durable responses and strong tolerability. Availability begins immediately via specialty networks, with dedicated patient support.

 

Treatment Breakthrough

Sun Pharma announced on January 15, 2026, that UNLOXCYT is now accessible to US healthcare professionals for prescribing to eligible aCSCC patients. This PD-L1 checkpoint inhibitor stands out with its multifaceted mechanism, restoring adaptive immunity, engaging innate responses, and preserving PD-L2 signaling, based on preclinical data. The recent FDA label update incorporates extended follow-up from the pivotal CK-301-101 trial, showing enhanced objective response rates, more complete responses, and prolonged duration without changes to safety profile.

 

Clinical Efficacy Insights

Trial results highlight UNLOXCYT's impact: at least 50 percent of patients achieved objective responses, including 13 percent complete responses in metastatic CSCC and 26 percent in locally advanced cases. Overall disease control reached 71 percent, incorporating stable disease, with median response duration unreached. Experts like Ann W. Silk, MD, from Dana-Farber Cancer Institute, praise its meaningful efficacy and suitability for older patients with comorbidities.

 

Key Trial Outcomes

Safety and Access

Common adverse reactions include fatigue, musculoskeletal pain, rash, and hypothyroidism, mostly Grade 1 or 2. Immune-mediated events were minimal, with only 0.9 percent Grade 3 dermatologic issues and rare Grade 2 pneumonitis. UNLOXCYT distributes through authorized specialty channels; professionals can access details at UNLOXCYTPro.com. The UNLOXCYT SUPPORT program aids affordability and resources for patients and providers. Richard Ascroft, CEO of Sun Pharma North America, emphasized commitment to immediate access.

 

Sources: Sun Pharma Press Release, PR Newswire, Express Pharma