MUMBAI, INDIA, PRINCETON - Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, 'Sun Pharma')) announced UNLOXCYT (cosibelimab-ipdl) is now available in the U.S. for healthcare professionals to prescribe for adults with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation.
'Patients with unresectable or metastatic CSCC now have a new and important treatment option to manage their disease. UNLOXCYT is a novel anti-PD-L1 antibody that is capable of antibodydependent cellular cytotoxicity and associated with clinically meaningful efficacy, as shown by a disease control rate of 71%,' said Ann W. Silk, MD, MS, medical oncologist at Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School. 'Because these patients tend to be older and have multiple comorbidities, it's extremely valuable to have a therapy that offers durable disease control and proven tolerability.'
'UNLOXCYT is an evolution in checkpoint inhibition, combining durable efficacy with a proven tolerability profile for a group of aCSCC patients who traditionally would struggle to strike that therapeutic balance,' said Richard Ascroft, CEO of Sun Pharma North America. 'Sun Pharma is committed to ensuring access from day one with the UNLOXCYT SUPPORTTM patient access and affordability program.'
The U.S. Food and Drug Administration (FDA) recently approved an updated label for UNLOXCYT to reflect long-term follow-up data from the pivotal CK-301-101 clinical trial. This study showed improvements in objective response rates (including more patients who achieved a complete response [CR]) and duration of response. The safety data did not change from the original UNLOXCYT label.
Many patients in the pivotal trial experienced durable responses with UNLOXCYT. At least 50% demonstrated an objective response (complete or partial response), including 13% of mCSCC patients and 26% of laCSCC patients who achieved complete response. 71% of patients achieved disease control with UNLOXCYT, including patients with stable disease. The median duration of response has not yet been reached in either treatment group.
Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, during or after discontinuation of treatment. Females should use effective contraception and avoid breastfeeding during treatment. The most common adverse reactions (ARs) were fatigue, musculoskeletal pain, rash, diarrhea, and hypothyroidism. Immune-mediated adverse reactions (imARs) were primarily Grade 1 or 2; 0.9% were Grade 3 (dermatologic only), with no Grade =4 imARs.
Of particular note, no patients developed Grade 3 or 4 pneumonitis. Just 0.9% (two patients) experienced pneumonitis (Grade 2). UNLOXCYT is available through a limited distribution network of authorized specialty distributors and one contracted specialty pharmacy. Healthcare professionals can visit UNLOXCYTPro.com for additional information. Sun Pharmaceuticals does not recommend the use of any particular distributor or specialty pharmacy. For comprehensive support, UNLOXCYT SUPPORT is dedicated to supporting healthcare professionals and patients by providing resources for their journey on UNLOXCYT.
About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma is among the most common skin cancers worldwide. While early stages are treatable, an estimated 40,000 US patients each year progress to advanced disease, resulting in nearly 15,000 deaths. Important risk factors for CSCC include chronic ultraviolet radiation exposure and immunosuppressive conditions. In addition to being life threatening, CSCC causes significant functional morbidities and cosmetic deformities due to tumors that commonly arise in the head and neck region and that invade blood vessels, nerves, and vital organs such as the eye or ear.
About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050)
Sun Pharma 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 is a leading generic company in the U.S. as well as global Emerging Markets. Sun Pharma's high-growth global Innovative Medicines portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for about 20% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations.
Contact:
Jeremy Allen
Tel: +1 640 230 1397
Email: jeremy.allen@sunpharma.com
Tel: (91-22) 4324 4324
Fax: (91-22) 4324 4343
Web: www.sunpharma.com
Email: secretarial@sunpharma.com
(C) 2026 Electronic News Publishing, source ENP Newswire