Takeda Receives Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer

Takeda (TSE:4502/NYSE:TAK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (mCRC). The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for mCRC throughout the European Union (EU), Norway, Liechtenstein and Iceland. If approved, fruquintinib will be the first and only selective inhibitor of all three VEGF receptors approved in the EU for previously treated mCRC.^1,2

“People living with metastatic colorectal cancer in the European Union currently have limited treatment options, which can lead to poor outcomes. With this positive opinion for fruquintinib, we are one step closer to potentially offering patients a new, oral, chemotherapy-free option that may provide a survival benefit,” said Awny Farajallah, M.D., chief medical officer, oncology at Takeda. “We look forward to the European Commission’s official decision in the near future as we work to redefine the treatment landscape and help address a significant unmet need for those affected by mCRC.”

The Committee’s positive opinion was primarily based on results from the Phase 3 multi-regional FRESCO-2 trial. The trial investigated fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated mCRC. FRESCO-2 met all its primary and key secondary efficacy endpoints and showed consistent benefit among patients treated with fruquintinib, regardless of the prior types of therapies they received. Fruquintinib demonstrated a manageable safety profile in FRESCO-2. Adverse reactions leading to treatment discontinuation occurred in 20% of patients treated with fruquintinib plus BSC versus 21% of those treated with placebo plus BSC. Data from FRESCO-2 were published in The Lancet in June 2023.³

About Fruquintinib

Fruquintinib is a selective oral inhibitor of VEGFR -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for potential use as part of combination therapy.