Sun Pharmaceutical Industries announced that UNLOXCYT® (cosibelimab-ipdl) has been elevated to a National Comprehensive Cancer Network® (NCCN®) Category 2A recommended option for patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not candidates for curative surgery or curative radiation.

This is an addition to the Category 2A designation in metastatic cutaneous squamous cell carcinoma (mCSCC), which was assigned to UNLOXCYT in 2025.

UNLOXCYT was approved by the U.S. Food and Drug Administration (FDA) in 2024 and is indicated for the treatment of adults with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation. The recommended dosage of UNLOXCYT is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks. UNLOXCYT is the first and only FDA approved PD-L1-blocking antibody for advanced CSCC (aCSCC).

The evidence submitted to NCCN in support of the change was based on the pivotal registration study, in which 55% of patients achieved an objective response, including 26% who achieved a complete response. Responses were durable: at a median follow-up of 24.1 months; median duration of response had not been reached (range: 8.3 to 31.3+ months). In addition, fewer than 1% of patients experienced a high-grade (Grade 3-5) immune-mediated adverse reaction (imARs)—an important consideration in this patient population. There were no grade 4 or 5 imARs.

NCCN is an alliance of 34 leading cancer centers in the U.S. Its Clinical Practice Guidelines in Oncology, referred to as the NCCN Guidelines, provide recommendations for the prevention, diagnosis, evaluation, and treatment of different types of cancer. The NCCN Guidelines are among the most influential clinical guidelines in cancer care, offering evidence-based, expert developed recommendations intended to help clinicians make treatment decisions for patients with cancer.