HATFIELD, England, March 3, 2011 /PRNewswire/ -- New data supporting the role of Eisai's Halaven(TM) (eribulin) as a potential new standard of care for women with heavily pretreated metastatic breast cancer (MBC) were published in The Lancet today. The EMBRACE trial (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice Versus Eribulin E7389) demonstrated that Halaven significantly improved overall survival (OS) compared with treatment of physician's choice (TPC) in women with MBC previously treated with at least an anthracycline and a taxane.[1] TPC is defined as any single-agent chemotherapy, hormonal treatment or biologic therapy approved for the treatment of cancer, or palliative treatment or radiotherapy administered according to local practice.[2]

"There is an urgent need for therapies with a proven survival benefit for women with metastatic breast cancer who have already received multiple treatments," commented Dr. Javier Cortes, lead author and investigator for the EMBRACE study and Specialist Physician at the Oncology Department of Vall d'Hebron University Hospital, Barcelona, Spain. "In the EMBRACE study we see a clear overall survival benefit for these patients when treated with Halaven. This is a remarkable step forward in this treatment setting where previously overall survival has been considered an endpoint difficult to attain."

EMBRACE met its primary endpoint, demonstrating a statistically significant increase in OS in the intention to treat (ITT) population for Halaven compared with TPC of 2.5 months (median 13.1 and 10.6 months respectively; p=0.041; hazard ratio [HR] 0.81). EMBRACE showed Halaven to have a predictable and manageable side effect profile with the most common adverse events in both arms being fatigue (53.7% with Halaven, 39.7% with TPC) and neutropaenia, or abnormally low levels of neutrophil white blood cells (51.7% with Halaven, 29.6% with TPC).[1]

"The publication of EMBRACE in The Lancet further reinforces the importance of Halaven as a potential new treatment for patients with metastatic breast cancer," said Uday Bose, Head of Institutional Care, Eisai Europe, Ltd. "These data open the door for a new treatment strategy in Europe, and one that will benefit patients who previously had very limited options. We are looking forward to the potential forthcoming authorisation of Halaven in Europe."

Halaven, a new, first-in-class type of chemotherapy, is a non-taxane, microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents. It is a structurally simplified synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.[3][4] Eisai recently received positive opinion from The Committee for Medicinal Products for Human Use (CHMP) for the use of Halaven as a monotherapy in 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 has already received FDA approval in the United States.