Officially announced today, Halaven ® (Eribulin) has received reimbursement approval from the Spanish Directorate General of Pharmacy and Health Products, belonging to the Spanish Ministry of Health, and is consequently available for patients with heavily pre-treated advanced or metastatic breast cancer, who previously had few efficient, therapeutic options available. Importantly, this novel agent has shown to improve survival by on average 20% in these patients whose disease progressed despite having previously been treated with at least two chemotherapy regimens.
Set to significantly improve metastatic breast cancer survival rates, Eribulin (a chemotherapy drug based on Halichondria okadai, a sea sponge of animal origin found in Japan Sea), represents an important breakthrough compared to other previous chemotherapeutic approaches since it is the first to be approved over the last ten years with the monotherapeutic capacity of prolonging life, without a significant toxicity, offering new hope for these patients.
Eribulin was approved by the EMA in 2011 further to the results of a Phase III Open-Label Randomised Study (EMBRACE) of Eribulin Monotherapy Versus Treatment of Physician´s Choice in Patients with Metastatic Breast Cancer*, published in The Lancet in March 2011. This multicenter study was first-authored and co-led by Javier Cortés, Principle Investigator of VHIO´s Breast Cancer and Melanoma Group.
“While such discovery represents significant progress in the war on metastatic breast cancer, we hope to better improve outcomes for our patients by combining Eribulin with biological therapies”, explains Javier Cortés.
Further collaborative studies involving VHIO´s Breast Cancer and Experimental Therapeutics Groups, are envisaged to explore the potential of Eribulin in combination with PI3K inhibitors. Based on this VHIO-led strategy, the first clinical trial in patients will start in a few months’ time. Results of these investigations could trigger a timely paradigm shift in the treatment and care of metastatic breast cancer patients.
* Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study.
Cortes J, O’Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Diéras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C., on behalf of the EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician´s Choice (TPC) Versus Eribulin E7389) invesigators Lancet 2011 Mar; 377(9769): 914-23