Sun Pharma's UNLOXCYT® gets NCCN Category 2A preferred designation

Sun Pharmaceutical Industries Limited announced that its drug UNLOXCYT® (cosibelimab-ipdl) has received a National Comprehensive Cancer Network® (NCCN®) Category 2A preferred designation for patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not candidates for curative surgery or radiation. This designation is an addition to its existing Category 2A designation for metastatic CSCC. UNLOXCYT, approved by the U.S. FDA in 2024, is the first and only FDA-approved PD-L1-blocking antibody for advanced CSCC. The pivotal study showed a 55% objective response rate, with 26% complete responses, and durable responses. The drug also demonstrated a low incidence of high-grade immune-mediated adverse reactions.