Takeda announced today that the European Commission has approved FRUZAQLA as a monotherapy for the treatment of adults with metastatic colorectal cancer (mCRC) who have previously undergone standard therapies. These include fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, as well as anti-VEGF and anti-EGFR agents, and who have either progressed on or are intolerant to trifluridine-tipiracil or regorafenib. This approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in April 2024 and FDA approval in the U.S. for similar indications in November 2023.

Josep Tabernero, MD, PhD, Director of Vall d´Hebron Institute of Oncology (VHIO), expressed optimism: "People with metastatic colorectal cancer face significant challenges from the disease and treatment side effects. Introducing innovative therapies like fruquintinib, an oral, chemotherapy-free targeted agent, is crucial. I am eager to provide patients with this new treatment option."

The EC's decision is supported by results from the Phase 3 FRESCO-2 trial, which compared FRUZAQLA plus best supportive care (BSC) to placebo plus BSC in previously treated mCRC patients. FRESCO-2 met all primary and key secondary efficacy endpoints, showing consistent benefits across patient subgroups regardless of prior therapy types. The safety profile of FRUZAQLA was manageable, with 20% of FRUZAQLA-treated patients experiencing adverse reactions leading to treatment discontinuation, compared to 21% in the placebo group. Results from FRESCO-2 were published in The Lancet in June 2023.

Teresa Bitetti, President of Takeda's Global Oncology Business Unit, noted the significance of the approval: "Today's milestone is crucial for the EU colorectal cancer community, providing patients with a new treatment option that offers a manageable safety profile and efficacy independent of prior therapies."

FRUZAQLA is a selective oral inhibitor of all three VEGF receptors (-1, -2, and -3), designed for enhanced selectivity and sustained target inhibition. Takeda holds the exclusive global license for developing, commercializing, and manufacturing fruquintinib outside mainland China, Hong Kong, and Macau.

 

Source: businesswire.com

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