Fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 to treat adult patients with previously treated metastatic colorectal cancer
A micrograph of colorectal cancer. (Credit: Mikael Häggström, M.D. from Wikimedia Commons)
Takeda and China-based HUTCHMED announced that the European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorisation application (MAA) for fruquintinib.
Under development by Japanese pharma major Takeda and Hutchmed, fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3.
It is designed to treat adult patients with previously treated metastatic colorectal cancer (CRC).
If approved, fruquintinib will become the first and only highly selective inhibitor of all three VEGF receptors approved in the European Union for previously treated metastatic CRC.
Takeda Global Medical Affairs Oncology head Awny Farajallah said: “We are thrilled to have submitted the marketing authorisation application to the EMA, bringing us one step closer to potentially offering this innovative therapy to patients with advanced disease.
“We believe fruquintinib has the potential to address the longstanding unmet need for patients with previously treated metastatic colorectal cancer regardless of their biomarker status, and we look forward to working with the regulators throughout the process.”
The MAA included findings from the Phase 3 FRESCO-2 trial along with data from the Phase 3 FRESCO trial conducted in China.
FRESCO-2 trial evaluated VEGFR inhibitor plus best supportive care (BSC) vs placebo plus BSC in patients with previously treated metastatic CRC.
The late-stage trial met its primary and key secondary endpoints, demonstrating a significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS), respectively.
HUTCHMED chief medical officer and R&D head Michael Shi said: “We believe the EMA validation of the marketing authorisation application for fruquintinib represents an exciting initial step toward advancing treatment for patients in Europe and look forward to supporting Takeda as it pursues this goal.”
The latest announcement follows the acceptance by the US Food and Drug Administration (FDA) of a new drug application (NDA).
In May, the FDA granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of 30 November 2023.
Additionally, both firms are planning to submit NDA in Japan.