FDA Approves Updated Label for Unloxcyt

WEDNESDAY, Dec. 3, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

The updated label incorporates long-term follow-up data from the pivotal CK-301-101 trial, which included 109 patients (31 with locally advanced and 78 with metastatic CSCC). Results showed patients receiving Unloxcyt experienced durable clinical responses, including for the primary end point of objective response rate, in which at least 50 percent of patients achieved an objective response. In addition, 14 percent of patients with metastatic CSCC and 32 percent of patient with locally advanced CSCC achieved stable disease. The median duration of response had not been reached in either group at the time of analysis. A rapid response was seen, with a median time to response of 1.9 months (range, 1.6 to 16.9) and 3.6 months (range, 1.7 to 10.1) in metastatic and locally advanced disease, respectively.

There were no changes to the safety profile of Unloxcyt in this label update, including immune-mediated adverse reactions, which occurred in 24 percent of participants. The most common adverse reactions (≥10 percent) included fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.

“This label update reinforces the importance of therapeutic diversity in advanced CSCC,” David Miller, M.D., Ph.D., from the Mass General Brigham Cancer Institute, said in a statement. “Having access to a treatment option that works in a different way than other checkpoint inhibitors can only benefit patients who are fighting this disease and demand an efficacious treatment with acceptable tolerability.”

This approval was granted to Sun Pharma.

More Information