Halaven(R) (eribulin), a novel treatment for patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease, is now available under national reimbursement in Italy. Prior therapy should have included two common types of chemotherapy, an anthracycline and a taxane, unless patients were not suitable for these treatments. Eribulin is the first, single-agent chemotherapy to demonstrate a prolonged overall survival in patients with heavily pre-treated advanced breast cancer when compared to an active control in the EMBRACE clinical trial.
Breast cancer is now the most common cancer in Italy with more than 47,500 cases diagnosed annually, and is the leading cause of death among women in Italy and worldwide. However, breast cancer mortality rates in Italy have shown a decline from the early 1990s, which is mainly attributable to advancements in treatments and the role of screening in detecting the cancer at an earlier stage.
“There is still a clear unmet need for new treatment options for women with heavily pre-treated metastatic or locally advanced breast cancer. The launch of eribulin in Italy marks a significant medical advance in a setting where there is currently no standard of care. Eribulin is an effective and well tolerated option that has been shown to extend life, offering women precious additional time to spend with their family and loved ones,” commented Professor Stefania Gori, AIOM Board Member.
“The reimbursement of eribulin in Italy is a positive step for women living with metastatic breast cancer who would have otherwise been faced with limited treatment options. Access to this novel chemotherapy means that eligible patients will benefit from a new treatment which significantly increases their survival, providing them with valuable extra time with their families. We are very proud to bring this new treatment to Italy, and are committed to improving the lives of our patients,” commented Laura Forni, Oncology Business Unit Head for Italy, Eisai Europe Ltd.
Discovered and developed by international pharmaceutical company Eisai, eribulin is a non-taxane, microtubule dynamics inhibitor and a synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Results of the pivotal Phase III study, EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician’s Choice (TPC) Versus Eribulin E7389), showed that patients treated with eribulin survived a median of 2.5 months longer than patients who received TPC (overall survival of 13.1 months vs. TPC 10.6 months, respectively p=0.014). An updated analysis demonstrated that patients treated with eribulin survived a median of 2.7 months longer than patients who received TPC (eribulin 13.2 months vs. TPC 10.5 months, nominal p=0.014).[1,2] TPC represents active treatment options currently used by doctors in real world clinical practice.
The most commonly reported adverse reactions among patients treated with eribulin were asthenia (fatigue), neutropenia, alopecia (hair loss), peripheral neuropathy (numbness and tingling in arms and legs), nausea and constipation.
Eribulin received European Commission approval on 17 March 2011 based on the results of the EMBRACE study. Eribulin is approved in the European Union, USA, Switzerland, Japan, and Singapore. Eribulin is currently commercially available in Austria, Denmark, Finland, Germany, Japan, Norway, Sweden, Singapore, Switzerland, United Kingdom, and the USA.
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 fulfill its human health care (hhc) mission.