Sun Pharma announced that the FDA approved a label update for UNLOXCYT™ (cosibelimab-ipdl), based on longer-term data. The updated label includes data demonstrating improved clinical outcomes in advanced cutaneous squamous cell carcinoma (aCSCC). The pivotal trial showed ≥50% of patients experiencing an objective response, with an improved median duration of response. The company intends to commercially launch UNLOXCYT in early 2026.
UNLOXCYT Label Update
Sun Pharma announced the U.S. Food and Drug Administration (FDA) approved an updated label for UNLOXCYT™ (cosibelimab-ipdl) on November 25, 2025. This update is for the treatment of adults with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
Key Trial Data
The updated label incorporates long-term follow-up data from the pivotal CK-301-101 trial, which included 109 patients. The results demonstrated durable clinical responses in patients receiving UNLOXCYT. At least 50% of patients in the trial achieved an objective response.
According to the study, 14% of mCSCC patients and 32% of IaCSCC patients achieved stable disease. The median duration of response had not been reached in either group at the time of the follow-up analysis.
Efficacy Results
Key efficacy endpoints from the updated analysis showed an objective response rate (ORR) of 50% in mCSCC patients (n=78) and 55% in IaCSCC patients (n=31). The median duration of response was not reached in either group.
Future Plans
Sun Pharma intends to commercially launch UNLOXCYT in early 2026. The company remains committed to advancing data-driven innovation and expanding differentiated immunotherapy treatment options.
UNLOXCYT Indication
UNLOXCYT (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (IaCSCC) who are not candidates for curative surgery or curative radiation.
Source: BSE