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FDA approves Takeda's fruquintinib in third-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. ....

Stefanie Granado , Takeda Pharmaceutical Co , Takeda Pharmaceutical , Takeda Pharmaceutical Co Ltd , Metastatic Colorectal Cancer , Hutchmed Ltd , Vegfr 1 ,

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. ....

Stefanie Granado , Takeda Pharmaceutical Co , Takeda Pharmaceutical , Takeda Pharmaceutical Co Ltd , Metastatic Colorectal Cancer , Hutchmed Ltd , Vegfr 1 ,

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 ....

United States , Al Qahirah , Cancer Institute , Hong Kong , Ahcene Djaballah , Gastroenterol Hepatol , Cathy Eng , Jun Saito , Teresa Bitetti , Michael Sapienza , Colorectal Cancer Alliance , Takeda Pharmaceutical Company Limited , National Cancer Institute , International Agency For Research On Cancer , International Normalized Ratio , China National Medical Products Administration , European Medicines Agency , Exchange Commission , Devices Agency , Takeda Pharmaceuticals , Vanderbilt University Medical Center , Japan Pharmaceuticals , Drug Administration , First Targeted Therapy Approved , Metastatic Colorectal Cancer , Biomarker Status ,