Sun Pharma Launches UNLOXCYT in the U.S. for Advanced Cutaneous Squamous Cell Carcinoma
- ipharmaservices
- 1 day ago
- 2 min read
Sun Pharmaceutical Industries has introduced UNLOXCYT (cosibelimab) in the United States for adult patients diagnosed with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are ineligible for curative surgery or radiation therapy.
Updated FDA Label Reflects Long-Term Efficacy
The U.S. FDA recently approved an updated label for UNLOXCYT following the release of extended follow-up data from the pivotal CK-301-101 clinical study. The findings confirmed durable responses over time, with improvements in objective response rates (ORR) and a greater proportion of patients achieving complete response (CR). The therapy’s safety profile remains consistent with the original label, demonstrating manageable tolerability.
In the clinical trial, approximately half of the treated patients achieved measurable tumor reduction, with 13% of those with mCSCC and 26% of those with laCSCC attaining complete response.
Overall, 71% of participants achieved disease control, including cases of stable disease. The median duration of response has yet to be reached, highlighting the therapy’s sustained efficacy.
Mechanism of Action and Clinical Value
UNLOXCYT represents an advancement in checkpoint inhibition, offering a dual-immune mechanism that reactivates the adaptive immune response while engaging innate immunity—uniquely preserving PD-L2 signaling, unlike other checkpoint inhibitors. This balanced approach contributes to both durable efficacy and a favorable tolerability profile.
Distribution and Support Program
UNLOXCYT is distributed through a limited network of specialty distributors and a single contracted specialty pharmacy. UNLOXCYT SUPPORT™ provides comprehensive assistance for healthcare professionals and patients, offering guidance and resources throughout treatment. More details are available at UNLOXCYTPro.com.
Understanding Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (CSCC) is one of the most prevalent skin cancers globally. While early-stage disease is highly treatable, roughly 40,000 U.S. patients annually progress to advanced disease, leading to nearly 15,000 deaths each year. Chronic sun exposure and immune suppression are major risk factors. Advanced CSCC can cause significant disfigurement and functional impairment, particularly in the head and neck region, where tumors may invade essential structures such as nerves, vessels, and organs.
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