FDA nod for Sun Pharma's Unloxcyt in mCSCC or laCSCC
India’s Sun Pharmaceutical Industries (BSE: 524715) today announced the US Food and Drug Administration (FDA) approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
The updated label now incorporates long-term follow-up data from the pivotal CK-301-101 trial, a multicenter, multicohort, open-label study of 109 patients (31 with laCSCC; 78 with mCSCC), which showed patients receiving Unloxcyt experienced durable clinical responses.
Sun gained rights to Unloxcyt along with its acquisition in March this year of Checkpoint Therapeutics (Nasdaq: CKPT) to acquire the US immunotherapy and targeted oncology company, in a deal valued at around $355 million.
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