Sun Pharma Announces UNLOXCYT™ Availability for aCSCC in U.S.

Sun Pharmaceutical Industries Limited has announced the availability of UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) in the United States. This treatment is specifically for patients who are not candidates for curative surgery or radiation. The announcement follows the U.S. FDA’s approval of an updated label for UNLOXCYT™, which includes long-term follow-up data from the pivotal CK-301-101 clinical trial.

The updated label for UNLOXCYT™ reflects improvements in objective response rates and duration of response. The clinical trial demonstrated that 71% of patients achieved disease control, with 50% showing an objective response, including complete or partial responses. The median duration of response has not yet been reached. The safety profile remains consistent with the original label, with the most common adverse reactions being fatigue, musculoskeletal pain, rash, diarrhea, and hypothyroidism.

UNLOXCYT™ is administered as an intravenous infusion at a dosage of 1,200 mg over 60 minutes every three weeks. It is available through a limited distribution network of authorized specialty distributors and one contracted specialty pharmacy. Healthcare professionals can access additional information through the UNLOXCYTPro.com website. Sun Pharmaceuticals does not recommend any specific distributor or specialty pharmacy.

The U.S. FDA’s approval of the updated label follows the pivotal CK-301-101 clinical trial, which provided long-term data confirming the durable efficacy and tolerability of UNLOXCYT™. The trial showed that 13% of mCSCC patients and 26% of laCSCC patients achieved complete response. The trial also highlighted that immune-mediated adverse reactions can occur, necessitating monitoring and management.

Sun Pharmaceutical Industries Limited, a leading specialty generics company, is responsible for the development and distribution of UNLOXCYT™. The company emphasizes the importance of ensuring access to the treatment from day one through the UNLOXCYT SUPPORT™ program, which provides resources for healthcare professionals and patients.

Cutaneous squamous cell carcinoma (CSCC) is one of the most common skin cancers worldwide. While early stages are treatable, approximately 40,000 U.S. patients progress to advanced disease annually, resulting in nearly 15,000 deaths. Important risk factors include chronic ultraviolet radiation exposure and immunosuppressive conditions. CSCC can cause significant functional morbidities and cosmetic deformities, particularly when tumors invade vital organs.

Sun Pharmaceutical Industries Limited is the world’s leading specialty generics company, with a presence in innovative medicines, generics, and consumer healthcare products. It is the largest pharmaceutical company in India and a leading generic company in the U.S. and global emerging markets. The company’s high-growth global Innovative Medicines portfolio spans dermatology, ophthalmology, and onco-dermatology, accounting for about 20% of company sales. Sun Pharma’s operations deliver high-quality medicines trusted by physicians and consumers in over 100 countries.