USFDA approves Takeda Fruzaqla for previously treated Metastatic Colorectal Cancer
Osaka: Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved FRUZAQLA (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
FRUZAQLA is the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated mCRC regardless of biomarker status. This approval was received under Priority Review more than 20 days ahead of the scheduled PDUFA date of November 30, 2023.
"There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes. FRUZAQLA is the first novel chemotherapy-free treatment option approved for patients in the U.S. regardless of biomarker status in more than a decade,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. “For far too long, healthcare providers and patients have had limited options when selecting a therapy for metastatic colorectal cancer. FRUZAQLA has the potential to offer a significant survival benefit to patients without negatively impacting their quality of life.”
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