|By PR Newswire||
|September 3, 2013 07:02 PM EDT||
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. 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."
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)., 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)., 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).
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 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
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. 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 without affecting the shortening phase and sequesters tubulin into non-productive aggregates.
Global Phase III Clinical Study 305 (EMBRACE)
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., 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.
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
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 8, 2016 08:00 PM EST Reads: 129
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Feb. 8, 2016 06:30 PM EST Reads: 164
SYS-CON Events announced today that VAI, a leading ERP software provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. VAI (Vormittag Associates, Inc.) is a leading independent mid-market ERP software developer renowned for its flexible solutions and ability to automate critical business functions for the distribution, manufacturing, specialty retail and service sectors. An IBM Premier Business Part...
Feb. 8, 2016 03:00 PM EST Reads: 573
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
Feb. 8, 2016 03:00 PM EST
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...
Feb. 8, 2016 02:00 PM EST Reads: 207
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
Feb. 8, 2016 02:00 PM EST Reads: 341
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Feb. 8, 2016 02:00 PM EST Reads: 377
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
Feb. 8, 2016 01:30 PM EST Reads: 172
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Feb. 8, 2016 12:45 PM EST Reads: 356
Advances in technology and ubiquitous connectivity have made the utilization of a dispersed workforce more common. Whether that remote team is located across the street or country, management styles/ approaches will have to be adjusted to accommodate this new dynamic. In his session at 17th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., focused on the challenges of managing remote teams, providing real-world examples that demonstrate what works and what do...
Feb. 8, 2016 12:30 PM EST Reads: 234
As enterprises work to take advantage of Big Data technologies, they frequently become distracted by product-level decisions. In most new Big Data builds this approach is completely counter-productive: it presupposes tools that may not be a fit for development teams, forces IT to take on the burden of evaluating and maintaining unfamiliar technology, and represents a major up-front expense. In his session at @BigDataExpo at @ThingsExpo, Andrew Warfield, CTO and Co-Founder of Coho Data, will dis...
Feb. 8, 2016 12:30 PM EST Reads: 142
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Feb. 8, 2016 12:00 PM EST Reads: 156
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 8, 2016 10:45 AM EST Reads: 383
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Feb. 8, 2016 10:15 AM EST Reads: 365
It's easy to assume that your app will run on a fast and reliable network. The reality for your app's users, though, is often a slow, unreliable network with spotty coverage. What happens when the network doesn't work, or when the device is in airplane mode? You get unhappy, frustrated users. An offline-first app is an app that works, without error, when there is no network connection.
Feb. 8, 2016 09:45 AM EST Reads: 169