Sun Pharmaceutical Industries Limited announced that UNLOXCYT™ (cosibelimab-ipdl) is now available in the U.S. for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. This marks a significant advancement in checkpoint inhibition, offering a new treatment option for patients with this aggressive form of skin cancer.

The updated U.S. Food and Drug Administration (FDA) label for UNLOXCYT reflects long-term follow-up data from the pivotal CK-301-101 clinical trial. This data demonstrated durable efficacy, with at least 50% of patients experiencing an objective response, including complete responses in 13% of mCSCC patients and 26% of laCSCC patients. The overall disease control rate was 71%. The median duration of response has not yet been reached.

UNLOXCYT offers a multifaceted mechanism of action, acting as a novel anti-PD-L1 antibody that supports restoration of the adaptive immune response and engages the innate immune system while preserving PD-L2 signaling. The drug is available through a limited distribution network, and Sun Pharma is providing support through the UNLOXCYT SUPPORT™ patient access and affordability program. Key adverse reactions include fatigue, musculoskeletal pain, rash, and diarrhea, with immune-mediated adverse reactions being manageable.