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Novel Life-Extending Metastatic Breast Cancer Treatment Now Available in Spain

HATFIELD, England, September 4, 2013 /PRNewswire/ --

Reimbursement granted for Halaven® (eribulin) for patients with locally advanced or metastatic breast cancer

Halaven® (eribulin), has today 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.[1] Eribulin is the first, single-agent chemotherapy to demonstrate a prolonged overall survival in patients with heavily pre-treated advanced breast cancer.[2]

In Spain, breast cancer is now the second most common cause of female cancer death[3] and approximately 22,000 cases of breast cancer are diagnosed annually.[3] Spain has one of the lowest breast cancer mortality[4] and incidence[5] rates in Europe which is attributable to Spain's significant investment in breast cancer screening programmes.[6] 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.[7] 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."  

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.  

"We are very proud that eribulin is now accessible to women with metastatic breast cancer in Spain. We have worked very hard to ensure that the cost of eribulin remains economically viable, especially in this tough economic climate. Eribulin will play a valuable role in improving metastatic breast cancer treatment options for women in Spain," commented Miguel Marcão Managing Director for Spain, Eisai Europe Ltd. "Eisai is working closely with regional health authorities to ensure life-extending eribulin reaches the patients that need it, as soon as possible."

In the Phase III EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice (TPC) Versus Eribulin E7389) study population (n=762), eribulin was shown to prolong overall survival in heavily pre-treated patients with metastatic breast cancer by 2.5 months compared to patients receiving Treatment of Physicians Choice (TPC), representing a mix of real-life treatment choices (eribulin 13.1 months vs. TPC 10.6 months, HR 0.81 (95% CI 0.66, 0.99) p=0.041).[1],[2] Updated data from the pivotal Phase III EMBRACE trial confirmed these results, showing that patients treated with eribulin survived a median of 2.7 months longer than patients who received treatment of physician's choice (overall survival of 13.2 months versus 10.5 months, respectively, HR 0.81 (95% CI 0.067, 0.96), nominal p=0.014).[1],[2] A pre-planned analysis of patients from Region 1 of the study (North America/Western Europe/Australia) showed a significant overall survival benefit of eribulin over TPC of 3.0 months (p=0.009).[2]

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.[2]

Eribulin received European Commission approval on 17 March 2011 based on the results of the Phase III EMBRACE study. Eribulin is approved in 50 countries across the world including the European Union, USA, Russia, Switzerland, South Korea Japan, and Singapore. Halaven has received pricing authorisation and has launched in Canada, Denmark, Finland, France, Iceland, Italy, Norway, Sweden, Switzerland, Slovenia, and the UK. In addition, Halaven is available in Austria and Germany.

Eisai is dedicated to discovering, developing and producing innovative oncology therapies that can make a difference and impact the lives of women and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to increase the benefits health care provides.

Notes to Editors

Halaven® (eribulin)

Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the treatment of patients with breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease and whose prior therapy should have included an anthracycline and a taxane.[1] Eribulin belongs to a class of antineoplastic agents, the halichondrins, which are natural products, isolated from the marine sponge Halichondria okadai.[8] It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into non-productive aggregates.

Global Phase III Clinical Study 305 (EMBRACE)[2]

EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice (TPC) Versus Eribulin E7389) was an open-label, randomised, global, multi-centre, parallel two-arm study designed to compare overall survival in patients treated with eribulin versus a Treatment of Physician's Choice (TPC) arm. TPC was 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 study included 762 patients with metastatic breast cancer who previously had been treated with at least two and a maximum of five prior chemotherapies, including an anthracycline and a taxane. The vast majority (96%) of patients in the TPC arm received chemotherapy.

The most commonly reported adverse reactions among patients treated with eribulin in the EMBRACE study were fatigue (asthenia), a decrease in infection-fighting white blood cells (neutropaenia), hair loss (alopecia), numbness and tingling in arms and legs (peripheral neuropathy), nausea and constipation. Peripheral neuropathy was the most common adverse event leading to discontinuation from eribulin, occurring in less than 5% of the patients involved in the EMBRACE trial. Neutropaenia only led to eribulin discontinuation for 0.6% patients. Death due to serious side effects, discontinuation and dose interruptions to treatment were lower in the eribulin arm of the trial compared with the TPC arm.

Metastatic Breast Cancer

Over 300,000 women are diagnosed with breast cancer in Europe every year, of whom about one third subsequently develop metastatic disease.[9],[10] Metastatic disease is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body.

Eisai in Oncology

Our 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 small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.

About Eisai

Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies, that has defined its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc).

Eisai concentrates its R&D activities in three key areas:

  • Oncology, including: anticancer therapies, tumour regression, tumour suppression and antibodies
  • Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss
  • Vascular/Immunological reaction, including: thrombocytopenia, rheumatoid arthritis, psoriasis and inflammatory bowel disease

With operations in the USA, Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa and Russia (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, the Middle East and Russia.

For further information please visit our web site http://www.eisai.co.uk


1. SPC Halaven (updated April 2013). Available at: http://www.medicines.org.uk/emc/medicine/24382. Last accessed August 2013

2. Cortes J, et al. The Lancet. 2011; 377: 914-923

3. GLOBOCAN. Breast Cancer in Spain. Available at: http://globocan.iarc.fr/factsheets/populations/factsheet.asp?uno=724 Last accessed October 2011

4. European Commission. Eurostat - causes of death statistics. Available from: http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Causes_of_death_statistics. Last accessed October 2011

5. Pollán M. et al. Journal of the National Cancer Institute 2009. 101 (22): 1584-1591.  

6. Pollán M. et al. Ann Oncol 2010; 21 Suppl 3: iii97-iii102

7. Borràs J. et al. 2010. Ann of Onc 21 (Suppl 3): ii 111-iii114

8. Jordan, MA et al. Mol Cancer Ther 2005;4:1086-95

9. Ferlay et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer.  2013; 49(6):1374-403

10. O'Shaughnessy, J. Extending Survival with Chemotherapy in Metastatic Breast Cancer. The Oncologist. 2005; 10(suppl 3):20-29

Date of preparation: September 2013


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