Eisai's Halaven cleared in Europe for advanced breast cancer

Japanese drug major Eisai (TYO: 4532) has received approval from the European Commission for Halaven (eribulin) for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease.

Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments. Halaven is a new class of agent which provides statistically significant overall survival improvements compared with current treatment options.

The European Commission approval of Halaven was granted through a centralized procedure, which means that the treatment has now been granted marketing authorization in the 27 EU member states. Eisai plans to launch Halaven first in the UK, followed by other countries such as Germany and Nordic countries.