Sun Pharmaceutical Industries Limited announced that its product, UNLOXCYT® (cosibelimab-ipdl), has been elevated to a National Comprehensive Cancer Network® (NCCN®) Category 2A recommended option. This designation is for patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not candidates for curative surgery or radiation. The NCCN Guidelines are highly influential in oncology treatment decisions and payer coverage.
Sun Pharma’s UNLOXCYT® Receives NCCN® Category 2A Recommendation
Sun Pharmaceutical Industries Limited announced a significant development for its oncology drug, UNLOXCYT® (cosibelimab-ipdl). The drug has been elevated to a National Comprehensive Cancer Network® (NCCN®) Category 2A recommended option. This prestigious recommendation applies to patients diagnosed with locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not suitable candidates for curative surgery or radiation therapy.
This updated designation in the NCCN Guidelines, a critical resource for oncologists in the U.S., follows the drug’s earlier Category 2A recommendation for metastatic cutaneous squamous cell carcinoma (mCSCC) assigned in 2025. UNLOXCYT® was initially approved by the U.S. Food and Drug Administration (FDA) in 2024 for treating adults with mCSCC or laCSCC who are not candidates for curative treatment.
Clinical Evidence and Expert Endorsement
The recommendation is supported by robust clinical evidence from a pivotal study where 55% of patients achieved an objective response, including 26% who achieved a complete response. The responses were observed to be durable, with a median duration not reached at a median follow-up of 24.1 months. Importantly, fewer than 1% of patients experienced high-grade (Grade 3-5) immune-mediated adverse reactions (imARs), with no grade 4 or 5 imARs reported.
Dr. Ahmad Naim, Senior Vice President, North American Chief Medical Officer, Sun Pharma, stated, “The elevation of UNLOXCYT to a Category 2A recommendation for patients with laCSCC marks an important milestone, validating the growing body of clinical evidence supporting UNLOXCYT and reflecting increasing confidence among oncology experts in its role as a treatment option for patients with this challenging disease.”
Dr. Francis Worden, Clinical Professor of Internal Medicine at the University of Michigan Rogel Cancer Center, commented, “This guideline update reflects the strength of the published evidence supporting the use of UNLOXCYT as first line treatment for laCSCC. In the pivotal study, patients experienced durable and clinically meaningful responses. UNLOXCYT also demonstrated a low incidence of high-grade imARs.”
The NCCN Guidelines significantly influence physician treatment decisions and payer coverage policies, ensuring better patient access to recommended therapies. This enhanced recommendation for UNLOXCYT® is expected to further solidify its position as a valuable treatment option for patients battling advanced cutaneous squamous cell carcinoma.
About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (CSCC) is a common form of skin cancer. While treatable in early stages, an estimated 40,000 U.S. patients annually progress to advanced disease, leading to approximately 15,000 deaths. Key risk factors include chronic ultraviolet radiation exposure and immunosuppressive conditions. Advanced CSCC can cause significant functional and cosmetic morbidities.
Source: BSE
