The blockbuster targeted anti-cancer drug Fruquintinib that I’ve been following has finally achieved new significant progress recently. According to information on the China National Drug Administration (CNDA, or NMPA), the approval status of the marketing application of Fruquintinib has changed to "Under approval". If everything goes well, Fruquintinib will soon receive the formal approval of CNDA and its marketing within the year is almost certain.
100% Chinese-produced targeted anti-center drug developed by Hutchison MediPharma for 13 years
Fruquintinib is a new, oral, highly selective VEGFR (receptor for vascular endothelial growth factor)-TKI (tyrosine kinase inhibitor) independently developed by Hutchison MediPharma with complete intellectual property, which, by acting on the target of VEGFR kinase family, can well inhibit tumor metastasis and tumor angiogenesis. According to the relevant clinical study, the drug has advantages such as low off-target toxicity, good drug tolerance, and strong action.
The process from a chemical formula to the upcoming marketing of Fruquintinib has taken 13 years. The drug was applied for clinical trial in September 2009, and approved for clinical trial in November 2010. Hutchison MediPharma reached a strategic cooperation agreement with Eli Lilly in October 2013, according to which, Eli Lilly would be responsible for the sales of Fruquintinib in China. Fruquintinib was filed for marketing application in June 2017, and was included in the priority review by reason of "having significant clinical value; major project" in September 2017.
The biggest characteristic of Fruquintinib is 100% Chinese-produced. The drug is the first one developed by a Chinese pharmaceutical enterprise, started clinical study among Chinese patients, and developed through cooperation of Chinese researchers; in simple terms, it is a targeted anti-cancer drug completely developed in a Chinese laboratory. And the drug is also the first new drug independently developed by Hutchison MediPharma in a real sense 15 years after establishment, with the clinical study for treating colorectal cancer approved as a "Major New Drug Invention Project" during the 12th Five-year Plan period of China. And Fruquintinib is also among the first varieties applied for new drug marketing in China’s Marketing Authorization Holder system pilot work.
The longest OS in the third-line treatment history of colorectal cancer (9.30 months)
Treatment of advanced colorectal cancer is based on chemotherapy at present, mainly of combined chemotherapy regimens. Colorectal cancer patients who failed first-line therapies are mainly treated with second-line chemotherapies, however, there is still no subsequent therapeutic regimen for patients who failed second-line standard treatment.
Fruquintinib Phase III clinical study FRESCO was a randomized, double-blind, placebo-controlled, multicenter clinical trial to assess the metastatic colorectal cancer patients who failed at least 2 rounds of treatment (including oxaliplatin, fluorouracil drug, and irinotecan), and the largest pivotal clinical study targeting advanced colorectal cancer so far in China. The study involved 28 research centers in China, and included a total of 416 subjects who were randomized to Fruquintinib group and placebo group according to 2:1 proportion. The study completely met all the predetermined trial endpoints; the median OS of patients in Fruquintinib group was 9.30 months, 2.73 months (P<0.001) significantly longer than that of the placebo group, with death risk reduced by 35% (hazard ratio HR=0.65). Compared to the placebo group, Fruquintinib group patients also had significantly longer PFS (3.71 months vs 1.84 months, P<0.001), reducing disease progression risk by 74% (HR=0.26).
The Phase III clinical study of Fruquintinib obtained the longest survival prolongation in the third-line treatment history of colorectal cancer worldwide. Patients in Fruquintinib group, whether having rece...
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