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HATFIELD, England/PRNewswire/ – The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), today gave a positive opinion for the use of Eisai Europe, Ltd.’s Halaven™ (eribulin) 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 of Leeds and St. James’s University Hospital, Leeds, UK.
“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.”
“This is very positive news for women with pretreated locally advanced or metastatic breast cancer,” said Professor Gordon McVie, senior consultant at the European Institute of Oncology in Milan.
“Halaven is a promising therapy for these patients who currently have very limited treatment options.”
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.
If it receives European Commission marketing authorisation, Eisai intends to make Halaven available throughout Europe.
Halaven received approval in the United States in November 2010 and applications are currently in progress in Japan, Canada, Singapore and Switzerland.
The UK’s National Institute for Health and Clinical Excellence (NICE) proposed Halaven as a Single Technology Appraisal (STA) in Wave 23.
“The CHMP positive opinion further supports Halaven’s role in this disease and draws us closer to making this important treatment available to patients,” said Uday Bose, Head of Institutional Care, Eisai Europe Ltd.
“True to our human health care philosophy, we remain committed to patients and their families and will continue to work closely with payers to ensure rapid and sustained patient access to Halaven across Europe.”