05 Sep 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Eribulin, an anticancer drug marketed by Japan-based Eisai under the trade name Halaven, has received reimbursement approval from the Spanish Directorate General of Pharmacy and Health Products, belonging to the Spanish Ministry of Health, as a novel treatment for patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. 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.
In Spain, breast cancer is now the second most common cause of female cancer death and approximately 22,000 cases of breast cancer are diagnosed annually. Spain has one of the lowest breast cancer mortality and incidence rates in Europe which is attributable to Spain's significant investment in breast cancer screening programmes. In addition, the Spanish Cancer Strategy's goal is to promote an integrated multidisciplinary approach to cancer care, with prompt access to diagnosis and therapy. The reimbursement of eribulin illustrates Spain's commitment to its strategy.
"As a scientific non-profit foundation that supports patients living with metastatic breast cancer, we believe that the approval of eribulin is a step towards a new treatment option for these patients," commented Dr Ana Lluch, member of the Board of GEICAM (Spanish Breast Cancer Research Group).
"Eribulin addresses an urgent need for new treatment options for women in Spain with advanced breast cancer who have previously received multiple treatments," commented Dr Javier Cortes, head of the Breast Cancer Programme, Vall d'Hebron Institute of Oncology and University Hospital, Barcelona, Spain. "Now that Halaven is approved for reimbursement in Spain it provides an important addition to the present therapy armamentarium for patients with advanced breast cancer. Women in Spain can now benefit from a treatment that has a proven overall survival benefit," Dr Cortes added.
Principal investigator Dr Javier Cortes was involved in the study design, data analysis and interpretation of the pivotal phase III EMBRACE clinical trial for eribulin. Spain recruited the largest number of patients from any one country to the trial and over 50 patients were recruited by the Vall d'Hebron University Hospital alone. This contributed to valuable physician and patient experience data that led to the EMA marketing approval of eribulin in March 2011.