Halaven® (eribulin) Receives European Commission Marketing Authorisation Approval (MAA) for Advanced Breast Cancer After Only

   Halaven® (eribulin) Receives European Commission Marketing Authorisation  Approval (MAA) for Advanced Breast Cancer After Only One Prior Chemotherapy    PR Newswire    HATFIELD, England, July 3, 2014  HATFIELD, England, July 3, 2014 /PRNewswire/ --  FOR EU MEDIA ONLY, EXCLUDING SWISS, GERMAN, UK AND NORDIC MEDIA                                             New, earlier use indication to benefit thousands of women across Europe   The European Commission (EC) has issued Marketing Authorisation Approval (MAA) for Halaven ^® (eribulin) in the treatment of patients with locally advanced or metastatic breast cancer (MBC) who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments. ^[ ^1]  "Eribulin remains the only single-agent chemotherapy proven to prolong overall survival in women with pre-treated metastatic breast cancer. Therefore, it's crucial that we have the flexibility to offer them eribulin as early as possible in the course of their disease. The survival benefit seen in women with HER2 negative cancers is particularly important as they represent about 80% of all women with breast cancer," commented Dr Chris Twelves, Professor of Clinical Cancer Pharmacology and Oncology, and Honorary Consultant in Medical Oncology at the University of Leeds and St James's Institute of Oncology.  The MAA for eribulin is based on clinical evidence from two global Phase III trials; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice Versus Eribulin) ^[ ^2] and study 301. ^[ ^3] These studies involved more than 1,800 women.  EMBRACE showed eribulin can prolong median overall survival in heavily pre-treated women with MBC compared to women receiving an alternative treatment of physician's choice by 2.7 months (13.2 vs 10.5 HR 0.81 (95% CI 0.67, 0.96) nominal p=0.014). The most commonly reported adverse reactions in the eribulin study arm were fatigue (asthenia), a decrease in infection-fighting white blood cells (neutropenia), hair loss (alopecia), numbness and tingling in arms and legs (peripheral neuropathy), nausea and constipation. ^[ ^1 ^] EMBRACE is one of only 25 studies to demonstrate a significant extension in overall survival (as primary or secondary endpoint) in MBC in the last 40 years. ^[ ^4]  Study 301, a head-to-head trial of eribulin vs capecitabine, had a co-primary endpoint of overall survival and progression-free survival. The study demonstrated a trend favouring improved overall survival with eribulin compared to capecitabine in the intention-to-treat population, although the improvement was not statistically significant. ^[ ^3 ^]  Women treated with eribulin had a median overall survival of 15.9 months versus 14.5 months with capecitabine (HR 0.879; 95% CI: 0.770-1.003; p=0.056). ^[ ^3 ^] For women with human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer, overall survival was 15.9 months for eribulin vs 13.5 months for capecitabine (HR 0.838; 95% CI: 0.715-0.983). ^[ ^3 ^] The most common adverse events reported for eribulin and capecitabine (≥20% all grades) were neutropenia (54% vs 16%), hand-foot syndrome (<1% vs 45%) alopecia (35% vs 4%), leukopenia (31% vs 10%), diarrhoea (14 vs 29%) and nausea (22% vs 24%), respectively. ^[ ^3 ^]  "Eisai is very pleased that eribulin is now indicated for use in women with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. This earlier use of eribulin will allow more women across Europe to receive the survival benefits that treatment with eribulin may provide. As a company, we continue to be committed to broadening access to eribulin to help redress the inequality between early and advanced breast cancer outcomes," said Gary Hendler, President Eisai Global Oncology Business Unit.  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.Eribulin belongs to a class of antineoplastic agents, the halichondrins, which are natural products, isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division.  Global Phase III Clinical Study 305 (EMBRACE) ^[ ^1 ^]  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 women treated with eribulin versus a 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 participants 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 participants in the TPC arm received chemotherapy.  In the total phase III EMBRACE study population, eribulin was shown to prolong median overall survival in heavily pre-treated women with metastatic breast cancer compared to women receiving TPC by 2.7 months (13.2 vs 10.5 HR 0.81 (95% CI 0.67, 0.96) nominal p=0.014). A pre-planned analysis of participants from Region 1 of the study (North America/Western Europe/Australia) showed a significant median overall survival benefit of eribulin over TPC of 3.0 months (nominal p=0.031).  The most commonly reported adverse reactions among people treated with eribulin in the EMBRACE study were fatigue (asthenia), a decrease in infection-fighting white blood cells (neutropenia), 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 women involved in the EMBRACE trial. Neutropenia only led to eribulin discontinuation for 0.6%. 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.  Global Phase III Study 301  ^[ ^3 ^]  Study 301 was an open-labelled, randomised, two-parallel-arm, multicentre study of eribulin versus capecitabine in 1,102 women with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes, either in the (neo) adjuvant setting or for locally advanced or metastatic disease. Women in the study received zero to two previous chemotherapies for advanced disease.  The study opened in 2006 and the last patient was randomised in 2010. Patients were randomised to treatment with either eribulin 1.23mg/m ^2 (administered intravenously over two to five minutes on days 1 and 8, every 21 days) or capecitabine 2.5g/m ^2 (administered orally twice daily in two equal doses on days 1 to 14, every 21 days).  Study 301 had a co-primary endpoint of OS and PFS. The study demonstrated a trend favouring improved OS with eribulin compared to capecitabine in the ITT population, although the improvement was not statistically significant. Women treated with eribulin had a median OS of 15.9 months (HR 0.879; 95% CI: 0.770-1.003; p=0.056) versus 14.5 months with capecitabine. The trial did not meet the pre-specified endpoint for progression-free survival, with 4.1 and 4.2 months for eribulin and capecitabine respectively (HR 1.079; 95% CI: 0.932-1.250; p=0.305).  1-,2- and 3- year overall survival rates for eribulin versus capecitabine showed an early improvement which was maintained throughout the study (1 year, 64.4% eribulin vs 58.0% capecitabine (P=0.0351), 2 year 32.8% eribulin vs 29.8% capecitabine (P=0.324), 3 year, 17.8% eribulin vs 14.5% capecitabine (P=0.175).  Unlike studies conducted today, study 301 included all women regardless of their human epidermal growth factor receptor 2 (HER2), oestrogen receptor (ER) or progesterone receptor (PR) status. Patients are usually tested for their HER2 status as there are now effective treatments specifically for patients with the HER2 mutation. HER2 positive patients would generally be treated with anti-HER2 positive targeted therapy. For women with HER2 negative metastatic breast cancer (n=755), OS was 15.9 months for eribulin vs 13.5 months for capecitabine (HR 0.838; 95% CI: 0.715-0.983). In the HER2 positive population, OS was 14.3 months for eribulin vs 17.1 months for capecitabine (HR; 95% 0.965; CI: 0.688-1.355).  Adverse events in Study 301 were consistent with the known profile of both drugs.  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. ^[5] ^, ^[6] 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 and we define our 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, antibodies, etc.   *Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight     loss   *Vascular/Immunological reaction including: thrombocytopenia, rheumatoid     arthritis, psoriasis, inflammatory bowel disease  With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (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, Luxembourg, Russia and the Middle East.  For further information please visit our web site http://www.eisai.co.uk  References   1. European Commission Implementing Decision for Halaven received June 2014  2. Cortes J, O'Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. The Lancet. 2011;377:914-923  3. Kaufman P, Awada A, Twelves C et al. A Phase III, open-label, randomised, multicenter study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes. Presented at 2012 CTRC-AACR San Antonio Breast Cancer Symposium  4. Data on File ERI-099 Improvement in Overall Survival in Metastatic Breast Cancer  5. World Health Organisation. Atlas of Health in Europe. 2003. World Health Organization, Regional Office of Europe, Copenhagen, Denmark.  6. Cancer Research UK. Breast cancer incidence statistics. http://www.cancerresearchuk.org/cancer-info/cancerstats/types/breast/incidence/#world [ http://www.cancerresearchuk.org/cancer-info/cancerstats/types/breast/incidence ]. Last accessed May 2014  Date of preparation: July 2014 Job code: Halaven-UK0302  Contact: Media Enquiries: Eisai Europe Ltd : Cressida Robson / Ben Speller , +44(0)7908 314 155 / +44(0)7947 231 513, Cressida_Robson@eisai.net, Ben_Speller@eisai.net ; Tonic Life Communications : Siobhan Reilly / April Kenneally, +44(0)207 798 9999 / +44(0)207 798 9263, siobhan.reilly@toniclc.com, april.kenneally@toniclc.com  
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