Takeda has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for 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 this recommendation when determining the potential marketing authorization for fruquintinib for mCRC across the European Union (EU), Norway, Liechtenstein, and Iceland. If approved, fruquintinib would be the first and only selective inhibitor of all three VEGF receptors approved in the EU for previously treated mCRC.
Awny Farajallah, M.D., Takeda’s chief medical officer for oncology, highlighted the significance of this milestone, emphasizing the potential of fruquintinib to offer patients a new, oral, chemotherapy-free treatment option with potential survival benefits. This positive recommendation follows comprehensive evaluation, with the CHMP primarily basing its decision on results from the Phase 3 FRESCO-2 trial, which investigated fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated mCRC. The trial successfully met all primary and key secondary efficacy endpoints, demonstrating consistent benefits across patients treated with fruquintinib, irrespective of their prior treatment regimens. Moreover, fruquintinib exhibited a manageable safety profile in the trial.
Fruquintinib functions as a selective oral inhibitor of VEGFR -1, -2, and -3, playing a crucial role in blocking tumor angiogenesis. Its enhanced selectivity minimizes off-target kinase activity, ensuring high drug exposure, sustained target inhibition, and potential flexibility for combination therapy. Takeda holds the exclusive worldwide license for the further development, commercialization, and manufacturing of fruquintinib outside mainland China, Hong Kong, and Macau. Fruquintinib, marketed as FRUZAQLA®, received approval from the U.S. Food and Drug Administration (FDA) in November 2023 and awaits review by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) following a submission in September 2023.
Regarding safety information, FRUZAQLA comes with several warnings and precautions, including the management of hypertension, hemorrhagic events, infections, gastrointestinal perforation, hepatotoxicity, proteinuria, palmar-plantar erythrodysesthesia (PPE), posterior reversible encephalopathy syndrome (PRES), impaired wound healing, arterial thromboembolic events, and allergic reactions. Additionally, due to potential embryo-fetal toxicity, caution is advised for pregnant women and those of childbearing potential, with the recommendation of effective contraception during and after treatment.
This recommendation underscores Takeda’s commitment to addressing the unmet needs of patients with metastatic colorectal cancer, offering a promising treatment option pending regulatory approval.
