Eisai Gets Fast Track for Eribulin

The FDA has granted Fast Track Status for the NDA of Eribulin, Eisai’s treatment for patients with locally advanced or metastatic breast cancer previously treated with at least two chemotherapy regimens, including an anthracycline and a taxane.

Eisai submitted simultaneous regulatory applications for the approval of eribulin in the U.S., Japan and the European Union (EU) on March 30, 2010. The company also has submitted regulatory applications for approval to health authorities in Switzerland and Singapore. Fast Track status should cut the review process from 10 months to six.