US EditionSun Pharma Receives US FDA Label Update Approval for UNLOXCYT
The updated FDA label for UNLOXCYT reflects long-term trial data showing at least 50% objective response rate and durable responses in advanced cutaneous squamous cell carcinoma.
- The U.S. Food and Drug Administration approved an updated label for UNLOXCYT, based on long-term data showing durable responses in advanced CSCC, announced by Sun Pharma.
- Longer-Term follow-up analyses revealed improved Objective Response Rates of 50% in the mCSCC cohort and 55% in the laCSCC cohort, with median Duration of Response not reached in both cohorts.
- The updated analysis reported no changes to the established safety profile, with immune-mediated adverse reactions in 53 patients and infusion-related reactions 11% , plus common adverse reactions including fatigue, rash, and hypothyroidism.
- Sun Pharmaceutical Industries Limited plans a commercial launch in early 2026 and will engage the National Comprehensive Cancer Network, positioning UNLOXCYT as the first and only PD-L1 immune checkpoint inhibitor for aCSCC.
- Given the unmet need, approximately 1 million annual CSCC diagnoses occur in the United States, with about 40,000 advanced cases and median time to response 1.9 months.
69 Articles
69 Articles
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)
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…
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)
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…
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)
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…
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)
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…
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)
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…
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)
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…
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