Sun Pharmaceutical Industries announced the availability of UNLOXCYT™ (cosibelimab-ipdl) in the U.S. for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (aCSCC) who are not candidates for curative surgery or radiation. UNLOXCYT offers a balanced treatment with long-term data confirming efficacy and tolerability. This new drug provides a novel treatment option for patients with limited alternatives. The company also provides UNLOXCYT SUPPORT™ for healthcare professionals and patients.
UNLOXCYT™ for aCSCC Treatment
January 15, 2026, Sun Pharmaceutical Industries announced that UNLOXCYT™ (cosibelimab-ipdl) is now accessible in the U.S. for healthcare professionals to prescribe. It is intended for adults suffering from metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (IaCSCC) where surgery or curative radiation are not viable options.
Treatment Benefits & Efficacy
UNLOXCYT™ is an evolution in checkpoint inhibition that offers a balanced approach to treatment. The updated label contains data confirming durable efficacy and a proven tolerability profile. 71% of patients achieved disease control with UNLOXCYT. It is also the first and only checkpoint inhibitor in aCSCC that helps restore the adaptive immune response while preserving PD-L2 signaling.
Supporting Access and Affordability
The company has launched UNLOXCYT SUPPORT™ to provide essential support to healthcare professionals and aCSCC patients, focused on patient access and affordability. 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, which showcased improvements in objective response rates and duration of response.
Important Safety Information
Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue. Monitor for early identification and management. The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection. The recommended dosage is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks.
About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma is among the most common skin cancers worldwide, with advanced stages affecting an estimated 40,000 US patients each year, leading to nearly 15,000 deaths. Key risk factors include chronic ultraviolet radiation exposure and immunosuppressive conditions.
Source: BSE
