EU Approves Takeda’s FRUZAQLA for Treated Metastatic Colorectal Cancer

Takeda has announced that the European Commission (EC) has approved FRUZAQLA (fruquintinib) as a monotherapy for adult patients with metastatic colorectal cancer (mCRC) who have previously been treated with standard therapies. These therapies include fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and patients who have progressed on or are intolerant to treatment with trifluridine-tipiracil or regorafenib. This approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2024, and approval by the U.S. FDA on November 8, 2023, for similar use.

“Metastatic colorectal cancer patients face significant challenges from both their disease and the side effects of treatments. The approval of fruquintinib, an oral, chemotherapy-free targeted agent, provides a much-needed new option for these patients,” said Dr. Josep Tabernero, director of Vall d´Hebron Institute of Oncology (VHIO).

The approval is based on results from the Phase 3 FRESCO-2 trial, which showed that FRUZAQLA plus best supportive care (BSC) significantly improved outcomes compared to placebo plus BSC in previously treated mCRC patients. FRUZAQLA demonstrated a manageable safety profile, with adverse reactions leading to treatment discontinuation in 20% of patients, compared to 21% in the placebo group. These results were published in The Lancet in June 2023.

“This approval is a significant milestone for the colorectal cancer community in the EU,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. “For the first time in over a decade, patients with previously treated metastatic colorectal cancer have a new targeted treatment option that works irrespective of tumor mutations.”

FRUZAQLA is a selective oral inhibitor of all three VEGF receptors (1, 2, and 3), crucial for blocking tumor angiogenesis. It was designed for enhanced selectivity to minimize off-target effects, allowing high drug exposure and sustained target inhibition. Takeda holds the exclusive global license to develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong, and Macau. In China, fruquintinib is marketed as ELUNATE® by HUTCHMED and was approved in September 2018.

For full safety information, consult the FRUZAQLA Summary of Product Characteristics (SmPC) before prescribing. The guidance includes important information on contraindications, special populations, and potential side effects such as hypertension, hemorrhagic events, gastrointestinal perforation, proteinuria, palmar-plantar erythrodysaesthesia syndrome (PPES), posterior reversible encephalopathy syndrome (PRES), impaired wound healing, and thromboembolic events.

FRUZAQLA should be initiated by a physician experienced in anticancer therapy. Women of childbearing potential should use effective contraception during treatment and for at least 2 weeks after the last dose. FRUZAQLA should not be used during pregnancy unless absolutely necessary, and breastfeeding should be discontinued during treatment and for 2 weeks after the last dose.

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