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

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).

Eribulin is currently indicated in Europe for the treatment of women with locally advanced or MBC who have previously received at least two chemotherapeutic regimens. Prior therapy should have included an anthracycline and a taxane unless women were not suitable for these treatments. Halaven is approved in the European Union, USA, Russia, Switzerland, South Korea, Japan and Singapore. Halaven has received pricing authorization and has launched in Austria, Canada, Denmark, Finland, France, Germany, Iceland, Italy, Luxembourg, Norway, Sweden, Switzerland, Slovenia and the UK.