Eisai Co., Ltd. announced today that it has received approval from the European Commission of the indication expansion of Halaven® (generic name: eribulin mesylate, “eribulin”) to contribute to earlier treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.

Halaven is currently indicated in Europe 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. The approval received from the European Commission is for the expansion of the current indication, which was limited to patients who had previously received at least two chemotherapeutic regimens, to include patients with metastatic breast cancer who have had less prior treatment. Through this indication expansion, Halaven will now be able to contribute at an earlier stage to patients with metastatic breast cancer in countries of the European Union.

For more details, go to: http://www.eisai.com/news/news201437.html