FDA approves label update for UNLOXCYT™ (cosibelimab-ipdl)
FDA approved an updated label for Sun Pharma's UNLOXCYT™ for advanced CSCC treatment, based on positive long-term trial data. Commercial launch is expected in early 2026.
The label update and planned commercial launch of UNLOXCYT could have a moderate impact on Sun Pharma's revenue and market position in the oncology segment.
The FDA approval of the updated label for UNLOXCYT and the positive clinical trial data are likely to be viewed favorably.
* FDA has approved an updated label for UNLOXCYT™ (cosibelimab-ipdl) for adults with metastatic CSCC or locally advanced CSCC. * The updated label incorporates long-term follow-up data from the pivotal CK-301-101 trial. * The trial included 109 patients and showed durable clinical responses with UNLOXCYT. * At least 50% of patients achieved the primary endpoint of objective response. * Median duration of response was not reached in either the mCSCC or laCSCC cohorts at the time of analysis. * Sun Pharma intends to commercially launch UNLOXCYT in early 2026.
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See the model portfoliosA plain-language summary of a public exchange filing by Sun Pharmaceutical Industries Limited. Read the original for the full detail.