HATFIELD, England, September 1, 2015 /PRNewswire/ --
PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN/U.S. JOURNALISTS
Halaven, a life-extending treatment, to be available earlier for women in Spain
From today, women with locally advanced or metastatic breast cancer (MBC) in Spain will have access to Halaven(R) (eribulin) after only one prior chemotherapy in the advanced setting. Eribulin is currently indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease in Spain. 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.
"Since eribulin is the only single-agent chemotherapy proven to prolong overall survival in women with metastatic breast cancer, it is great news that we are now able to offer this therapy after one prior chemotherapy in the metastatic setting. Of particular note is the survival benefit seen in women with HER2 negative cancers, as this represents around 80% of all women with breast cancer," commented Javier Cortes, Head of the Breast Cancer Programme, Vall d'Hebron Institute of Oncology and University Hospital, Barcelona, Spain.
Breast cancer is the most common female cancer in Spain. There were over 25,000 diagnosed cases of breast cancer in women in Spain in 2012 with over 6,000 deaths resulting from the disease.
The decision 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 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 the only one of 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 (greater than or equal to20% all grades) were neutropenia (54% vs 16%), hand-foot syndrome (