China’s equivalent of the U.S. FDA is expected in the coming days to approve fruquintinib, the leading drug from Chinese drug maker Chi-Med, for patients with advanced colon cancer who have already tried two or more chemotherapies.
China has never unconditionally approved an innovative drug that was discovered and developed by its own scientists for a common oncology indication. Nor has it exported a homegrown drug to the wider world in the modern era. Chi-Med is being closely watched because of the precedent it could set for a coming wave of Chinese companies developing homegrown drugs for China — while also setting its sights on the rest of the world.
In addition to the anticipated Chinese approval of fruquintinib, a targeted therapy that is designed to cut off blood flow to solid tumors, Chi-Med is also running a phase 1 safety trial testing the drug in the U.S., where it hopes to eventually get it approved for use, in combination with immunotherapies or chemotherapies, in cancers that are underserved or tough to treat.
Chi-Med’s pill is the latest in the class of VEGFR inhibitors; fruquintinib appears to have fewer side effects than other drugs in the class, and few of those were serious. Globally, these types of drugs are approved for about 30 different types of solid tumors. But in China, they’re approved for fewer than 10.
Fruquintinib performed well in a phase 3 trial that enrolled 416 colon cancer patients. Those on Chi-Med’s pill lived longer overall and without progression of their cancer compared with those taking a placebo alongside the standard of care. The data were published in June in the Journal of the American Medical Association.
With close to 400,000 new cases a year, colon cancer is China’s fourth most common cancer and its fifth most deadly.
Source: STAT News, September 4, 2018
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