Hutchmed (HCM) announced that it will receive a milestone payment following the pricing approval and launch of Fruzaqla 1mg/5mg capsules in Japan by its partner Takeda (TAK) for patients with previously treated metastatic colorectal cancer, or CRC. This follows approval for the manufacturing and marketing of Fruzaqla by the Japanese Ministry of Health, Labour and Welfare. Fruzaqla is the first novel oral targeted therapy in Japan to be approved for metastatic CRC, regardless of biomarker status, in over a decade. Fruzaqla is indicated for the treatment of advanced or recurrent colorectal cancer that is neither curable nor resectable, and that has progressed after chemotherapy. The launch of Fruzaqla in Japan follows its approval in September, primarily based on results from the Phase III FRESCO-2 trial conducted in the U.S., Europe, Japan and Australia. Data from FRESCO-2 were published in The Lancet in June 2023. Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau, and markets under the Fruzaqla brand name. It received approval in the U.S. in November 2023, in the EU in June, in Switzerland in August, in Canada, Japan and the United Kingdom in September and in Argentina, Australia and Singapore in October. Regulatory applications are progressing in many other jurisdictions.
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Read More on HCM:
- Hutchmed announces new, updated data from sovleplenib ESLIM-01 trial
- Hutchmed to receive $20M milestone payment from Takeda for Fruzaqla sales
- Hutchmed announces results from SAVANNAH trial
- Hutchmed, Takeda receive Japan MHLW approval to manufacture and market Fruzaqla
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