Eisai’s ERIBULIN RECEIVES CHMP POSITIVE OPINION FOR USE IN METASTATIC BREAST CANCER

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 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).[i] 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.[ii]
“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, 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”.
“This is very positive news for women with pretreated locally advanced or metastatic breast cancer” added Professor Gordon McVie, senior consultant at the European Institute of Oncology in Milan. “Eribulin is a promising therapy for these patients who currently have very limited treatment options”.
Eribulin, 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.[iii],[iv]
If it receives European Commission marketing authorisation, Eisai intends to make eribulin available throughout Europe. Eribulin 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 eribulin as a Single Technology Appraisal (STA) in Wave 23.[v]
“The CHMP positive opinion further supports eribulin’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 eribulin across Europe”
The study of 762 patients with locally recurrent or metastatic breast cancer who were previously treated with at least two and a maximum of five prior chemotherapies (≥ 2 for advanced disease), including an anthracycline and a taxane. Patients must have been refractory to the most recent chemotherapy, documented by progression on or within six months of therapy. The study was designed to compare overall survival in patients treated with eribulin versus a TPC arm, reflecting a real-world clinical setting where a variety of agents are used to treat patients with advanced breast cancer. TPC is defined as any single-agent chemotherapy, hormonal treatment or biologic therapy approved for the treatment of cancer, or palliative treatment or radiotherapy administered according to local practice. The primary endpoint was OS. Secondary endpoints were objective response rate, progression-free survival, safety and duration of response.
Eribulin is a non-taxane, microtubule dynamics inhibitor, belonging to a class of antineoplastic agents, the halichondrins, which are natural products isolated from the marine sponge Halichondria okadai. Eribulin targets microtubules, the major cytoskeletal component of cells which play a pivotal role in cell replication. Alteration of microtubule dynamics can cause a cell to stop dividing and self destruct.