Halaven™ (eribulin) is a novel treatment for patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced. Prior therapy should have included two common types of chemotherapy, an anthracycline and a taxane, unless patients were not suitable for these treatments. Discovered and developed by Eisai, Halaven is a non-taxane, microtubule dynamics inhibitor and a synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. It is a new class of agent and the first, single-agent chemotherapy to demonstrate a statistically significant overall survival benefit in patients with heavily pre-treated advanced breast cancer compared to currently used treatments. Patients treated with Halaven survived a median of 2.5 months longer than patients who received treatment of physician’s choice (overall survival of 13.1 months versus 10.6 months, respectively, p=0.041).
Eisai plan to launch Halaven in the Nordic zones in the next couple of weeks and the rest of Europe later in the year.
Breast cancer is the most common cancer in the UK. And in the EU, an estimates 332,670 new cases of breast caner occurred in 2008 alone.
It accounts for around 16% of female deaths from cancer, the second most common cause of female cancer death after lung cancer; 30% of women diagnosed with early or localised breast cancer will eventually relapse and develop metastatic or advanced disease.
“Eribulin addresses an urgent need for new treatment options for women with advanced breast cancer who have previously received multiple treatments,” says Dr Andrew Wardley, Consultant Medical Oncologist and Co-Chair of the Breast Group at The Christie Hospital in Manchester.
Halaven received European Commission approval on 17 March 2011 based on the results of the global Phase III EMBRACE study (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice (TPC) Versus Eribulin E7389).
The most commonly reported adverse reactions among patients treated with Halaven were asthenia (fatigue), neutropenia, alopecia (hair loss), peripheral neuropathy (numbness and tingling in arms and legs), nausea and constipation.
“As a charity that supports patients living with metastatic (secondary) breast cancer, we have heard from many UK women that they feel there are limited treatment options available to them. The UK launch of eribulin is a step towards a drug being made available to these patients which could help give them precious extra time,” commented Maria Leadbeater, clinical nurse specialist – metastatic (secondary) breast cancer, Breast Cancer Care.
Eisai’s commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop low molecular weight organic compounds, therapeutic vaccines, monoclonal antibody-based therapies, biologics, and supportive care agents for cancer across multiple indications. Through these efforts, Eisai will make further contributions to addressing the diversified needs of and increasing the benefits provided to patients and their families as well as healthcare professionals as it seeks to fulfil its human health care (hhc) mission.
