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Eribulin receives European commission marketing authorisation approval for advanced breast cancer after only one prior chemotherapy

The European Commission (EC) has issued Marketing Authorisation Approval (MAA) for eribulin in the treatment of patients with locally advanced or metastatic breast cancer (MBC) who have progressed after at least one chemotherapeutic regimen for advanced disease.

Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.

"Eribulin remains the only single-agent chemotherapy proven to prolong overall survival in women with pre-treated metastatic breast cancer. Therefore, it’s crucial that we have the flexibility to offer them eribulin as early as possible in the course of their disease. The survival benefit seen in women with HER2 negative cancers is particularly important as they represent about 80% of all women with breast cancer,” commented Dr Chris Twelves, Professor of Clinical Cancer Pharmacology and Oncology, and Honorary Consultant in Medical Oncology at the University of Leeds and St James’s Institute of Oncology.

The MAA for eribulin is based on clinical evidence from two global Phase III trials; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice Versus Eribulin) and study 301.

These studies involved more than 1,800 women.

EMBRACE showed eribulin can prolong median overall survival in heavily pre-treated women with MBC compared to women receiving an alternative treatment of physician’s choice by 2.7 months (13.2 vs 10.5 HR 0.81 (95% CI 0.67, 0.96) nominal p=0.014).

The most commonly reported adverse reactions in the eribulin study arm were fatigue (asthenia), a decrease in infection-fighting white blood cells (neutropenia), hair loss (alopecia), numbness and tingling in arms and legs (peripheral neuropathy), nausea and constipation.

EMBRACE is one of only 25 studies to demonstrate a significant extension in overall survival (as primary or secondary endpoint) in MBC in the last 40 years.

Study 301, a head-to-head trial of eribulin vs capecitabine, had a co-primary endpoint of overall survival and progression-free survival.

The study demonstrated a trend favouring improved overall survival with eribulin compared to capecitabine in the intention-to-treat population, although the improvement was not statistically significant.

Women treated with eribulin had a median overall survival of 15.9 months versus 14.5 months with capecitabine (HR 0.879; 95% CI: 0.770-1.003; p=0.056).

For women with human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer, overall survival was 15.9 months for eribulin vs 13.5 months for capecitabine (HR 0.838; 95% CI: 0.715-0.983).

The most common adverse events reported for eribulin and capecitabine (≥20% all grades) were neutropenia (54% vs 16%), hand-foot syndrome (<1% vs 45%) alopecia (35% vs 4%), leukopenia (31% vs 10%), diarrhoea (14 vs 29%) and nausea (22% vs 24%), respectively.

“Eisai is very pleased that eribulin is now indicated for use in women with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. This earlier use of eribulin will allow more women across Europe to receive the survival benefits that treatment with eribulin may provide. As a company, we continue to be committed to broadening access to eribulin to help redress the inequality between early and advanced breast cancer outcomes,” said Gary Hendler, President Eisai Global Oncology Business Unit.

Source: Eisai



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