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Eisai launches breast cancer drug Halaven in Italy

Follows conclusion of reimbursement negotiations last year

Eisai has launched its breast cancer drug Halaven (eribulin) in Italy after agreeing reimbursement terms.

The drug is licensed to treat locally advanced or metastatic breast cancer in patients who have progressed after at least two chemotherapeutic regimens for the advanced stage of the disease.

Eisai Europe's oncology business unit head for Italy Laura Forni said: "The reimbursement of eribulin in Italy is a positive step for women living with metastatic breast cancer who would have otherwise been faced with limited treatment options.

“Access to this novel chemotherapy means that eligible patients will benefit from a new treatment which significantly increases their survival, providing them with valuable extra time with their families.”

To be considered for use, patients should have already received two common types of chemotherapy, an anthracycline and a taxane, unless those treatments were not suitable.

Halaven's Italian debut follows earlier European launches in Austria, Denmark, Finland, Germany, Norway, Sweden, Switzerland and the UK.

Halaven was approved in Europe in March 2011 and in the US in November 2010.

Its approval was based on results from the phase III open-label, randomised, global, multi-centre study, EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice (TPC) Versus Eribulin E7389).

This involved 762 patients and showed that patients treated with Halaven 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).

TPC represents active treatment options currently used by doctors in real world clinical practice, and the majority (96 per cent) of patients in the TPC arm received chemotherapy.

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.

In agreeing the drug's reimbursement, Italy authorities have stipulated that it must initially be subject to intensive monitoring for suspicious adverse reactions.

Halaven is a non-taxane, microtubule dynamics inhibitor and a synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.

It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into non-productive aggregates.

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.

"There is still a clear unmet need for new treatment options for women with heavily pre-treated metastatic or locally advanced breast cancer. The launch of eribulin in Italy marks a significant medical advance in a setting where there is currently no standard of care," said Professor Stefania Gori, a member of the board of the Associazione Italiana di Oncologia Medica (AIOM).

26th January 2012

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