(Alliance News) - Hutchmed (China) Ltd on Friday said that its partner Takeda Pharmaceutical Co Ltd has been notified that the Committee for Medicinal Products for Human Use of the European Medicines Agency recommends approval for fruquintinib.
Shares in Hutchmed were down 6.7% at USD17.76 each in London on Friday afternoon.
The Hong-Kong based developer of treatments for cancer and immunological diseases said that the recommended approval of fruquintinib is for the treatment of patients with previously treated metastatic colorectal cancer.
This means that the European Commission will now consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for metastatic CRC throughout the European Union, Norway, Liechtenstein and Iceland.
If approved, fruquintinib will be the first and only selective inhibitor of all three vascular endothelial growth factor receptors approved in the EU for previously treated metastatic CRC, Hutchmed explained.
Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau.
"Through our partnership with Hutchmed, we have made strides in expanding access to fruquintinib to eligible patients. With this positive CHMP opinion for fruquintinib, we are one step closer to potentially offering patients in the EU an oral, chemotherapy‑free option that can provide a significant survival benefit," said Takeda Chief Medical Officer Awny Farajallah.
By Sabrina Penty, Alliance News reporter
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