The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Halaven (eribulin) for 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 new license for eribulin will give physicians and their patients more choice and flexibility when treating women with advanced breast cancer. Being able to use this active and well-tolerated treatment after only one prior chemotherapy regimen for metastatic disease will mean many more women benefit from this proven life-extending therapy,” 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 CHMP opinion for eribulin is based on clinical evidence from two global Phase 3 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 versus 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 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 (HR 0.879; 95% CI: 0.770-1.003; p=0.056). The most common adverse events reported for eribulin and capecitabine (≥20% all grades) were neutropenia (54% versus 16%), hand-foot syndrome (<1% versus 45%) alopecia (35% versus 4%), leukopenia (31% versus 10%), diarrhea (14 versus 29%) and nausea (22% versus 24%), respectively.
“Despite the advances that have been made in early breast cancer care, women with advanced disease remain underserved with much poorer prognoses. For this reason, Eisai is delighted that the CHMP has recognized the survival benefits that earlier treatment with eribulin may provide women with this condition. These two pivotal Phase 3 clinical trials show that we are committed to broadening access to eribulin to help redress the inequality between early and advanced breast cancer outcomes,” said Gary Hendler, president and CEO, Eisai EMEA.
Since the launch of eribulin in the United States in 2010, 49,000 women have been treated with eribulin globally. Based on the ruling, European Commission approval of the new indication for eribulin is anticipated within three months. The indication extension application for eribulin was not submitted in the United States following discussions with the U.S. Food and Drug Administration (FDA).
Date: May 27, 2014
Filed Under: Drug Discovery