Fast-approval designation for Eisai's E7090 in Japan

8 April 2019

Japanese pharma major Eisai (TYO: 4523) says that its in-house discovered fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor E7090 has been granted the Sakigake designation by Japan’s Ministry of Health, Labor and Welfare for the treatment of unresectable biliary tract cancer with FGFR2 gene fusion.

The Sakigake Designation System promotes R&D in Japan aiming at early practical applications for innovative new medicines and other product, and is similar to the USA’s Breakthrough Therapy designation and Europe’s PRIME status.

E7090 selectively inhibits FGFR1, FGFR2 and FGFR3, and is currently under development as a novel orally available anticancer agent. In Japan, E7090 is currently being investigated in a first in human study (Phase I clinical study) targeting patients with solid tumors including cholangiocarcinoma harboring FGFR2 gene fusion.

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