Locally advanced or metastatic breast cancer drug approved in Europe

3 Jul 2014

The European Commission has approved a drug for patients with locally advanced or metastatic breast cancer, named eribulin. The approval applies for patients whose tumor has progressed after at least one chemotherapeutic regimen for advanced disease.

This 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 3 trials:

  1. EMBRACE (which stands for "Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice Versus Eribulin") and
  2. "Study 301".

These studies involved more than 1,800 women.

"EMBRACE": One of only 25 studies in the last 40 years to show survival improvement

EMBRACE showed eribulin can prolong median overall survival in heavily pre-treated women with metastatic breast cancer compared to women receiving an alternative treatment of physician’s choice by 2.7 months (13.2 months compared to 10.5 months).

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 metastatic breast cancer in the last 40 years.

"Study 301": improvement in survival, for HER2 negative metastatic breast cancer in particular

"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 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.

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%), diarrhea (14 vs 29%) and nausea (22% vs 24%), respectively.


Source: eCancer News

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