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Takeda Gains European Commission Approval for Fruzaqla in Metastatic Colorectal Cancer

The European Commission (EC) has granted approval for Fruzaqla (fruquintinib) as a monotherapy for adults with metastatic colorectal cancer (mCRC) who have previously undergone standard treatments. These treatments include fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, as well as anti-VEGF and anti-EGFR agents. Additionally, this approval applies to patients who have either progressed on or cannot tolerate trifluridine-tipiracil or regorafenib.

This decision comes after a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2024, and follows the U.S. Food and Drug Administration (FDA) approval on November 8, 2023, for adults with mCRC treated with oxaliplatin- and irinotecan-based regimens.

The approval is anchored on findings from the Phase 3 FRESCO-2 trial, a global, multi-regional study. This trial assessed the efficacy of Fruzaqla in combination with best supportive care (BSC) against a placebo plus BSC in patients with previously treated mCRC. The study achieved all primary and key secondary endpoints, showing significant benefits with Fruzaqla, regardless of prior treatments.

Fruzaqla was also found to have a manageable safety profile. In the trial, 20% of patients on Fruzaqla plus BSC discontinued treatment due to adverse reactions, compared to 21% on placebo plus BSC.

Fruzaqla functions as a selective oral inhibitor of all three VEGF receptors (-1, -2, and -3). VEGFR inhibitors are crucial in preventing tumor angiogenesis. FRUZAQLA's design enhances selectivity, reducing off-target kinase activity and allowing for high drug exposure, sustained target inhibition, and potential combination therapy use.

Takeda holds the exclusive worldwide rights to develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong, and Macau.

The FDA approved Fruzaqla in November 2023, and a submission to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) was made in September 2023. In China, HUTCHMED develops and markets fruquintinib.

The China National Medical Products Administration (NMPA) approved it for marketing in September 2018, and it launched commercially in China under the brand name ELUNATE in November 2018.


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