Fruquintinib is said to be a highly selective and potent inhibitor of vascular endothelial growth factor receptors -1, -2 and -3, designed to treat adults with previously treated metastatic colorectal cancer

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Takeda global headquarter in Tokyo, Japan. (Credit: Takeda Pharmaceutical Company Limited)

Takeda and Hong Kong-based biopharmaceutical company Hutchmed announced that the US Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib.

Fruquintinib is said to be a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3. The drug is designed to treat adults with previously treated metastatic colorectal cancer (CRC).

If authorised, the cancer drug will be the first and only highly selective inhibitor of each of the three VEGF receptors authorised in the US for metastatic CRC that has already received treatment, Hutchmed said.

The FDA has set 30 November 2023 as the Prescription Drug User Fee Act (PDUFA) goal date for the NDA.

Takeda Oncology global medical affairs head Awny Farajallah said: “There are significant needs for patients with this disease in the US, and we believe fruquintinib has the potential to address these needs regardless of patients’ biomarker status.

“We look forward to continuing conversations with the FDA with the goal to make this therapy available to patients as soon as possible.”

The oral inhibitor’s NDA included findings from the late-stage FRESCO-2 trial along with data from the Phase 3 FRESCO trial conducted in China.

FRESCO-2 is a global Phase 3 multi-regional trial that compared fruquintinib plus best supportive care (BSC) to placebo plus BSC in patients with metastatic CRC who have already received treatment.

According to the biopharmaceutical firm, the overall survival (OS) and progression-free survival (PFS) were significantly and clinically meaningfully improved in the FRESCO-2 study, which also fulfilled its primary and key secondary endpoints.

HUTCHMED chief medical officer and R&D head Michael Shi said: “The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialisation in China.

“We are pleased to have Takeda as our partner furthering the development and commercialisation of fruquintinib outside of China.”

In China, fruquintinib is cleared for use under the brand name Elunate.

In March this year, both firms signed a licensing agreement to advance the global development, commercialisation, and production of fruquintinib outside of China.