FDA Approves Takeda’s Novel, Chemotherapy-Free Pill Fruzaqla for Metastatic Colorectal Cancer

November 10, 2023

The FDA approved Takeda’s Fruzaqla, a pill treatment for refractory metastatic colorectal cancer (mCRC), making it the first targeted therapy cleared for an all-comer population of mCRC in over a decade. This pill is the first chemotherapy-free option to offer a survival benefit despite prior treatments. The approval is based on two Phase 3 clinical trials (FRESCO and FRESCO-2) that demonstrated Fruzaqla’s significant improvements in overall and progression-free survivals. Regulatory applications are pending in Europe and Japan. Takeda licensed the drug, a selective oral inhibitor of VEGFR -1, -2, and -3, from Hutchmed. Two of Takeda’s other experimental assets were halted, but the company achieved potential second-half U.S. approvals for Fruzaqla and Adzynma. Colorectal cancer, which in 70% of patients causes metastatic disease, is the third most prevalent worldwide.

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[Source: MM+M, November 10th, 2023]

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