Eisai files for new Halaven indication; gets orphan status for lenvatinib in EU

8 May 2013

Japanese drug major Eisai (TYO: 4523) has filed a Type II Variation application with the European Medicines Agency for Halaven (eribulin), requesting an indication extension to include treatment of earlier line metastatic breast cancer (MBC) patients.

Eribulin is the first and only single-agent therapy proven to significantly extend overall survival after two prior lines of MBC therapy when compared to other single-agent therapies, says Eisai. Results from a pivotal Phase III study (EMBRACE) demonstrated a statistically significant median overall survival benefit for women treated with eribulin compared with a single-agent treatment of physician's choice (TPC).

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