Eisai's Halaven Receives CHMP Positive Opinion for use in Metastatic Breast Cancer
CHMP Opinion Based on Positive EMBRACE Study Data
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), gave a positive opinion for the use of Eisai Europe, Ltd.'s Halaven as a monotherapy indicated in the treatment of patients with locally advanced (LA) or metastatic breast cancer (MBC) who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
The CHMP submission was supported by results from the global Phase III EMBRACE study (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice (TPC) Versus Eribulin E7389) which demonstrated an overall survival (OS) benefit for patients treated with eribulin of 2.7 months compared with TPC (13.2 months versus 10.5 months, hazard ratio 0.805, nominal p=0.014). This is the first time that a monotherapy has provided statistically significant OS improvements in MBC patients previously treated with an anthracycline and a taxane in this patient population.
"EMBRACE is a pivotal study in locally advanced and metastatic breast cancer, demonstrating eribulin to be an effective and well-tolerated treatment for heavily pretreated patients" said Dr.Chris Twelves, lead investigator for the EMBRACE study and Professor of Clinical Cancer Pharmacology and Oncology from the University ofLeedsand St. James's University Hospital,Leeds, United Kingdom"Eribulin has a proven survival benefit and looks set to become the new standard of care in this disease setting and the positive CHMP opinion is a welcome step in making this important treatment available to the patients that need it".
Halaven, a new type of chemotherapy, is a non-taxane, microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents. It is a structurally simplified synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.
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