Eisai’s breast cancer drug Halaven receives MAA in Europe

The European Commission has issued Marketing Authorization Approval (MAA) for Halaven (eribulin) from Japanese drug major Eisai (TYO: 4523) 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. The MAA for eribulin is based on clinical evidence from two global Phase III trials; EMBRACE and study 301, which 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. 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 versus capecitabine, had a co-primary endpoint of overall survival and progression-free survival. The study demonstrated a trend favoring 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. 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.