Positive CHMP recommendation for Fruzaqla (fruquintinib) in previously treated metastatic colorectal cancer.- Takeda

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.

“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 III 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 ( previously cited).