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Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colo

− FRUZAQLA is the First Targeted Therapy Approved for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status or Prior Types of Therapies in More Than a Decade− FRUZAQLA Plus Best Supportive Care Demonstrated Significant Improvements in Overall Survival, with Corresponding Improvements in Progression Free.

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Takeda Receives U.S. FDA Approval of FRUZAQLA fruquintinib for Previously Treated Metastatic Colorectal Cancer

Takeda TSE4502NYSETAK today 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 irinotecanbased chemotherapy an antiVEGF therapy and if RAS wildtype and medically appropriate an antiEGFR therapy.

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FDA approves Takeda's fruquintinib in second-line metastatic colorectal cancer

The U.S. FDA approved Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib) nearly 20 days ahead of its Nov. 30 PDUFA date for adults with previously treated metastatic colorectal cancer. “Fruzaqla is the first targeted therapy approved in the U.S. for mCRC regardless of biomarker status or prior types of therapies in more than a decade,” Stefanie Granado, head of Takeda’s U.S. Oncology business unit, told BioWorld.

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Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

OSAKA, Japan & CAMBRIDGE, Mass., November 08, 2023 Takeda (TSE:4502/NYSE:TAK) today 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

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