SUNPHARMA: UNLOXCYT GETS NCCN CATEGORY 2A PREFERRED DESIGNATION IN laCSCC
SUNPHARMA
• NCCN elevated UNLOXCYT (cosibelimab-ipdl) to a 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 adds to the Category 2A designation for metastatic CSCC (mCSCC) received by UNLOXCYT in 2025
• UNLOXCYT was FDA approved in 2024 and is the first and only FDA-approved PD-L1-blocking antibody for advanced CSCC
• In the pivotal registration study, 55% of patients achieved an objective response, including a 26% complete response rate; at a median follow-up of 24.1 months, median duration of response had not been reached
• Fewer than 1% of patients experienced high-grade (Grade 3–5) immune-mediated adverse reactions, with no Grade 4 or 5 immune-mediated adverse reactions reported
• NCCN Guidelines can influence payer coverage policies, prior-authorization criteria, institutional formularies and clinical pathways, supporting broader patient access
Impact: Positive — The NCCN Category 2A recommendation in laCSCC expands the clinical positioning of UNLOXCYT and could support broader adoption and payer access for Sun Pharma’s cutaneous oncology portfolio in the US.