Eisai announced today that it 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.[i],[ii]

The European Commission approval of Halaven was granted through a centralised procedure, which means that the treatment has now been granted marketing authorisation in the 27 EU member states. Halaven will be launched in the EU during April 2011.

The approval of European Commission is based on the results of the global Phase III EMBRACE study (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice (TPC) Versus Eribulin E7389), which demonstrated a statistically significant increase in overall survival (OS) for patients treated with Halaven when compared with TPC*. The protocol prespecified analysis at the point of 422 events demonstrated a median OS of 13.1 and 10.6 months, respectively (Hazard Ratio [HR] 0.81; p=0.041);1 the updated analysis requested by European and US regulatory authorities including 589 events demonstrated a median OS of 13.2 and 10.5 months, respectively (HR 0.81; nominal p=0.014).2

Halaven is the first single-agent therapy to demonstrate a significant overall survival benefit in patients with advanced breast cancer. The European Commission approval means that patients across the EU will soon be able to benefit from this treatment, which offers them an average of more than 2 months longer life.

Halaven was approved in the USA in November 2010 and Singapore in February 2011, and has already been launched in USA.　The approval by European Commission is the third in the world, other applications are currently under review in Japan, Switzerland and Canada.

Eisai's commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, biologic and supportive care agents for cancer across multiple indications. Through these efforts, Eisai will make further contributions to addressing the diversified needs of and increasing the benefits provided to patients and their families as well as healthcare professionals as it seeks to fulfill its human health care (hhc) mission.

*Treatment of Physician's Choice (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.

Source: Esai Europe

References:

[i] Cortes J, O'Shaughnessy J, Loesch D, et al. A Phase III open-label randomized study (EMBRACE) or eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer. The Lancet. 2011; 377: 914 -923

[ii] Twelves C et al. Updated Survival Analysis of a Phase III Study (EMBRACE) of Eribulin Mesylate Versus Treatment of Physician's Choice in Subjects with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline and a Taxane. San Antonio Breast Cancer Symposium (SABCS) 2010; Poster P6-14-18.

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8 Cancer Research UK, Breast Cancer Statistics – Key Facts [updated April 2010]. Available from: http://info.cancerresearchuk.org/cancerstats/types/breast/index.htm?script=true (accessed (04/08/10)

9 Fernandez Y, Cueva J, Palomo AG, et al. Novel therapeutic approaches to the treatment of metastatic breast cancer. Cancer Treat Rev.2010:36(1):33-42