Pharma MNC Sun Pharma has announced that the US FDA has approved an updated label for UNLOXCYT (cosibelimab-ipdl), a treatment for adults with advanced skin cancer who cannot undergo surgery or radiation.

 

The update reflects long-term clinical trial data showing that many patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) experienced lasting responses, with some responding in as little as two months.

 

The data is from the pivotal CK-301-101 trial, a multicenter, multicohort, open-label study of 109 patients—31 with laCSCC and 78 with mCSCC.

 

A total of 53 patients (24%) experienced immune-mediated adverse reactions (imARs), mostly low-grade. Only two patients (0.9%) experienced high-grade imARs, both Grade 3 dermatologic events. No treatment-related deaths occurred.

 

UNLOXCYT works by restoring the adaptive immune response, enabling T cells to recognize cancer cells through PD-L1 inhibition and engaging the innate immune system via an Fc domain that activates natural killer (NK) cells for antibody-dependent cytotoxicity. The therapy also spares PD-L2, potentially limiting off-target immune effects in non-tumor tissues.

 

“The longer-term results confirm that UNLOXCYT represents an advancement in the available treatment options for people living with aCSCC,” said Richard Ascroft, CEO, Sun Pharma North America. “As a company committed to addressing the unmet needs of the patient communities we support, these pivotal data highlight that more patients responded and maintained their responses to UNLOXCYT for longer than observed in the primary analysis. The updated label reinforces UNLOXCYT as an evolution in checkpoint inhibition.”

 

Initially approved by the FDA in 2024, UNLOXCYT’s updated label underscores Sun Pharma’s commitment to data-driven innovation and expanding immunotherapy options in cutaneous oncology. The company plans a commercial launch in early 2026.

 

“While there have been advances in aCSCC treatment, there still remains a significant unmet need for therapies that provide durable, long-term efficacy with acceptable tolerability. This is especially important in this aging population who are dealing with significant comorbidities,” said Emily Ruiz, Associate Professor of Dermatology, Harvard Medical School. 

 

“For many aCSCC patients who are over the age of 65 and dealing with comorbidities, UNLOXCYT provides an important, new treatment option that balances both efficacy and tolerability.”