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Published on 26 January 2012

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Halaven® available in Italy for breast cancer

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Halaven® (eribulin), a novel treatment for patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease, is now available under national reimbursement in Italy.

Prior therapy should have included two common types of chemotherapy, an anthracycline and a taxane, unless patients were not suitable for these treatments.

Eribulin is the first, single-agent chemotherapy to demonstrate a prolonged overall survival in patients with heavily pre-treated advanced breast cancer when compared to an active control in the EMBRACE clinical trial.

Breast cancer is now the most common cancer in Italy, with more than 47,500 cases diagnosed annually, and is the leading cause of death among women in Italy and worldwide.

However, breast cancer mortality rates in Italy have shown a decline from the early 1990s, which is mainly attributable to advancements in treatments and the role of screening in detecting the cancer at an earlier stage.

“There is still a clear unmet need for new treatment options for women with heavily pre-treated metastatic or locally advanced breast cancer,” said Professor Stefania Gori, Associazione Italiana di Oncologia Medica Board Member.

“The launch of eribulin in Italy marks a significant medical advance in a setting where there is currently no standard of care.

“Eribulin is an effective and well tolerated option that has been shown to extend life, offering women precious additional time to spend with their family and loved ones.”

Discovered and developed by international pharmaceutical company Eisai, eribulin is a non-taxane, microtubule dynamics inhibitor and a synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.

Results of the pivotal Phase III study, EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician’s Choice (TPC) Versus Eribulin E7389), showed that patients treated with eribulin survived a median of 2.5 months longer than patients who received TPC (overall survival of 13.1 months vs. TPC 10.6 months, respectively p=0.014).

An updated analysis demonstrated that patients treated with eribulin survived a median of 2.7 months longer than patients who received TPC (eribulin 13.2 months vs. TPC 10.5 months, nominal p=0.014).

TPC represents active treatment options currently used by doctors in real world clinical practice.

The most commonly reported adverse reactions among patients treated with eribulin were asthenia (fatigue), neutropenia, alopecia (hair loss), peripheral neuropathy (numbness and tingling in arms and legs), nausea and constipation.

Eribulin received European Commission approval on 17 March 2011 based on the results of the EMBRACE study.

Eribulin is approved in the European Union, USA, Switzerland, Japan, and Singapore. Eribulin is currently commercially available in Austria, Denmark, Finland, Germany, Japan, Norway, Sweden, Singapore, Switzerland, United Kingdom, and the USA.

Associazione Italiana di Oncologia Medica



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