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FDA approves label update for UNLOXCYT™ (cosibelimab-ipdl) based on longer-term data that demonstrated improved clinical outcomes in advanced cutaneous squamous cell carcinoma (aCSCC)
Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) today announced the U.S. Food and Drug Administration (FDA) approved an updated label for UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic 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
About this update from Sun Pharmaceutical Industries Limited
[{"type":"list","items":[{"val":[{"type":"text","content":"As the first and only PD-L1 immune checkpoint inhibitor approved for aCSCC, UNLOXCYT is an evolution in checkpoint inhibition, offering a balance of durable clinical responses and acceptable tolerability—a key consideration for a patient population that is often living with other comorbidities.","length":305,"tagName":"p"}]},{"val":[{"type":"text","content":"The pivotal open-label UNLOXCYT trial included patients with metastatic CSCC (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. The long-term follow-up analysis demonstrated an improvement in the primary endpoint, objective response rate (ORR), including more complete responses compared with the primary analysis for both groups, with ≥50% of patients experiencing an objective response.","length":451,"tagName":"p"}]},{"val":[{"type":"text","content":"The median duration of response (DOR) (secondary endpoint) improved with longer follow-up and was not reached in either the mCSCC or laCSCC cohorts at the time of analysis, highlighting the durability of responses observed with UNLOXCYT.","length":237,"tagName":"p"}]},{"val":[{"type":"text","content":"There were no changes to the safety profile of UNLOXCYT, including immune-mediated adverse reactions (imARs), with this label update.","length":133,"tagName":"p"}]},{"val":[{"type":"text","content":"The long-term results from the pivotal open-label study of UNLOXCYT in aCSCC were published in the Journal of the American Academy of Dermatology (JAAD), further validating the strength of the data.","length":203,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":1329,"olType":false},{"type":"text","content":"MUMBAI, India and PRINCETON, N.J., Nov. 25, 2025 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) today announced the U.S. Food and Drug Administration (FDA) approved an updated label for UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic 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 multicent...