Eribulin mesylate was approved by the US Food and Drug Administration (FDA) on 15 November 2010, to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease, including both anthracycline- and taxane-based chemotherapies.
Eisai said the EC’s decision is supported by the results from a Phase III EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician’s Choice (TPC) Versus Eribulin E7389), study which showed increase in overall survival for patients treated with Halaven when compared with TPC.
The company intends to introduce the product in first in the UK, followed by other countries such as Germany and Nordic countries.