Regulators in Europe have approved Eisai’s marine-derived breast cancer drug Halaven.
The Japanese drugmaker received approval from the European Commission for Halaven (eribulin) for the treatment of patients with locally advanced breast cancer who have progressed after at least two chemotherapy regimens. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
The approval is based on the phase III EMBRACE study which demonstrated that Halaven superiority when compared with treatment of physician's choice (TPC). That data demonstrated median overall survival of 13.2 versus 10.5 months.
Eisai plans to launch Halaven first in the U.K., followed by Germany and the Nordic countries. It was approved in the U.S. in November 2010 and in Singapore this year, while other applications are currently under review in Japan, Switzerland and Canada.