Sun Pharmaceutical Industries Limited has announced the availability of UNLOXCYT™ (cosibelimab-ipdl) in the United States for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or radiation. The FDA-approved therapy offers a new treatment option for patients with advanced disease who face limited alternatives.
UNLOXCYT is the first and only checkpoint inhibitor in aCSCC that combines adaptive immune restoration with innate immune engagement while preserving PD-L2 signaling. The treatment has shown durable efficacy and a well-established tolerability profile. Clinical data from the pivotal CK-301-101 trial demonstrated a disease control rate of 71%, with complete responses observed in 13% of mCSCC patients and 26% of laCSCC patients. The median duration of response has not yet been reached.
The therapy is associated with immune-mediated adverse reactions, which can affect any organ system. The most common side effects reported include fatigue, musculoskeletal pain, rash, diarrhea, and hypothyroidism. Serious adverse events were rare, with only 0.9% experiencing Grade 3 dermatologic reactions and no Grade ≥4 immune-mediated reactions reported. No cases of severe pneumonitis were observed.
UNLOXCYT is available through a limited distribution network of authorized specialty distributors and a contracted specialty pharmacy. Healthcare professionals can access resources and patient support through the UNLOXCYT SUPPORT™ program, which provides assistance for both clinicians and patients navigating treatment.
Cutaneous squamous cell carcinoma is one of the most common skin cancers globally. Advanced cases can be life-threatening and cause significant functional and cosmetic impairments, particularly when tumors involve the head, neck, or vital organs. In the United States, approximately 40,000 patients progress to advanced CSCC annually, leading to nearly 15,000 deaths.
UNLOXCYT provides a new immunotherapy option for patients with advanced CSCC who have limited treatment choices, marking a significant step forward in the management of this aggressive skin cancer.
Also Read