Sun Pharmaceutical Industries Limited (NSE:SUNPHARMA, BSE:524715), an India-based specialty generic drug company, announced on Thursday that UNLOXCYT (cosibelimab-ipdl) is now available in the United States for healthcare professionals to prescribe for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
The US Food and Drug Administration (FDA) recently approved an updated label for UNLOXCYT to reflect long-term follow-up data from the pivotal CK-301-101 clinical trial. This study showed improvements in objective response rates (including more patients who achieved a complete response) and duration of response. Safety data was unchanged from the original UNLOXCYT label.
UNLOXCYT is available through a limited distribution network of authorised specialty distributors and one contracted specialty pharmacy.
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