(Alliance News) - Hutchmed China Ltd on Friday celebrated a priority review granted by the US FDA for its cancer drug fruquintinib, and promised to present new data for this and two other therapies at the American Society of Clinical Oncology next month.
Hutchmed is a Hong Kong-based cancer and immunological diseases treatment developer. It has partnered with Takeda Pharmaceutical Co Ltd, a Tokyo-based drug manufacturing company, for the further development and commercialisation of fruquintinib.
The US Food & Drug Administration has granted a new drug application priority review of fruquintinib, an inhibitor of three vascular endothelial growth factor receptors in adults with previously treated metastatic colorectal cancer.
Hutchmed said the drug, if approved, will be the first and only inhibitor of all three receptors approved for that condition in the US.
The new drug application includes results from its Phase 3 Fresco-2 clinical trial conducted in the US, Europe, Japan and Australia, and the Fresco trial conducted in China. Hutchmed said the Fresco-2 trial showed "a significant and clinically meaningful improvement" in overall survival and progression-free survival rates in patients given fruquintinib compared with those given a placebo. Fruquintinib is approved in China based on the Fresco study results.
"The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialisation in China," said Michael Shi, Hutchmed's chief medical officer and head of research & development.
"Today's acceptance marks a significant advancement towards the goal of providing patients with previously treated metastatic colorectal cancer a much-needed therapeutic option, given the limited treatment options currently available to patients. This also supports our ongoing vision to design and develop differentiated molecules that help patients with high unmet needs globally."
Hutchmed also on Friday announced that new and updated clinical data will be presented at the ASCO annual meeting which will take place between June 2-6 in Chicago and online. The data relate to fruquintinib as well as surufatinib and HMPL-453, two other investigational cancer therapies developed by Hutchmed. It will include new analyses from the Fresco-2 study.
Shares in Hutchmed were 4.6% higher at 215.00 pence in London on Friday.
By Emma Curzon, Alliance News reporter
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