Hutchmed, Takeda's Fruquintinib Accepted for Regulatory Review by EMA

By Michael Susin

Hutchmed (China) and Takeda Pharmaceutical said Thursday that the European Medicines Agency has accepted the marketing authorization application for fruquintinib, a treatment for previously-treated metastatic colorectal cancer, for regulatory review.

The companies said that if approved, fruquintinib will be the first treatment of its type in the European Union.

"We are thrilled to have submitted the marketing authorization application to the EMA, bringing us one step closer to potentially offering this innovative therapy to patients with advanced disease," Takeda's head of Global Medical Affairs Oncology Awny Farajallah said.

The application includes positive data from a last stage clinical trial, which demonstrated superiority of the therapy when compared with a placebo, it added.

Write to Michael Susin at michael.susin@wsj.comto Michael Susin at michael.susin@wsj.com

(END) Dow Jones Newswires

June 15, 2023 11:15 ET (15:15 GMT)

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