|By PR Newswire||
|January 5, 2014 07:02 PM EST||
HATFIELD, England, January 6, 2014 /PRNewswire/ --
Halaven® (eribulin) has received reimbursement approval in the Czech Republic as a highly innovative drug for patients with metastatic breast cancer, effective from the 1 January 2014. Eribulin is the first, single-agent chemotherapy to demonstrate a prolonged overall survival in patients with heavily pre-treated advanced breast cancer, compared to other single agent chemotherapies.
"The reimbursement of eribulin in the Czech Republic is an important step forward for women with metastatic breast cancer," says Professor MUDr. Bohuslav Melichar, PhD, the Scientific Secretary of the Czech Society for Oncology. "These patients urgently need new treatment options and in particular, therapies which have demonstrated an overall survival benefit in heavily pre-treated patients. The advent of eribulin will be welcomed by patients and doctors across the country."
Breast cancer is the most common cancer in Czech women and accounts for nearly 25% of all newly diagnosed malignancies in the female population. More than 6,400 people are diagnosed with breast cancer each year in the Czech Republic and metastatic disease will develop in approximately 30% of cases.
"Metastatic breast cancer continues to affect many women across Europe. We are pleased that the Czech health authorities recognise the innovative drug status and clinical value eribulin may offer to women with locally advanced or metastatic breast cancer," commented MUDr, Miloš Živanský, Medical Director of CEE in Eisai. "The reimbursement in the Czech Republic underscores the potential importance of this treatment and Eisai will work closely with local health authorities to ensure that women in the Czech Republic have rapid access to a treatment that has a proven overall survival benefit."
Eribulin received European Commission approval on 17 March 2011 based on the results of the pivotal Phase III EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice (TPC) Versus Eribulin E7389) study.Eribulin is now available in 50 countries worldwide.
In the EMBRACE 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 confirmed 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.
Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with cancer. Built on scientific expertise, Eisai 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.
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.
In the total Phase III EMBRACE study population, eribulin was shown to prolong median overall survival in heavily pre-treated patients with metastatic breast cancer compared to patients receiving TPC by 2.7 months (13.2 vs 10.5 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 median overall survival benefit of eribulin over TPC of 3.0 months (nominal p=0.031).
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 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
1. SPC Halaven (updated August 2013). Available at: http://www.medicines.org.uk/emc/medicine/24382. Last accessed October 2013
2. Epidemiology of breast cancer in the Czech Republic. Mamo.cz. http://www.mamo.cz/index-en.php?pg=professionals--breast-cancer-epidemiology Last accessed November 2013
3. Globocan 2008 statistics http://globocan.iarc.fr/factsheet.asp Last accessed October 2013
4. 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
5. World Health Organization. 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 November 2013.
Date of preparation: December 2013
Job code: Halaven-UK0227
"In the IoT space we are helping customers, mostly enterprises and industry verticals where time-to-value is critical, and we help them with the ability to do faster insights and actions using our platform so they can transform their business operations," explained Venkat Eswara, VP of Marketing at Vitria, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 6, 2015 04:30 PM EDT Reads: 203
SYS-CON Media announced today that CloudBees, the Jenkins Enterprise company, has launched ad campaigns on SYS-CON's DevOps Journal. CloudBees' campaigns focus on the business value of Continuous Delivery and how it has been recognized as a game changer for IT and is now a top priority for organizations, and the best ways to optimize Jenkins to ensure your continuous integration environment is optimally configured.
Jul. 6, 2015 04:30 PM EDT Reads: 800
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, it is now feasible to create a rich desktop and tuned mobile experience with a single codebase, without compromising performance or usability.
Jul. 6, 2015 04:30 PM EDT Reads: 733
The most often asked question post-DevOps introduction is: “How do I get started?” There’s plenty of information on why DevOps is valid and important, but many managers still struggle with simple basics for how to initiate a DevOps program in their business. They struggle with issues related to current organizational inertia, the lack of experience on Continuous Integration/Delivery, understanding where DevOps will affect revenue and budget, etc. In their session at DevOps Summit, JP Morgenthal...
Jul. 6, 2015 04:15 PM EDT Reads: 1,488
"We provide a web application framework for building really sophisticated web applications that run on a browser without any installation need so we get used for biotech, defense, and banking applications," noted Charles Kendrick, CTO and Chief Architect at Isomorphic Software, in this SYS-CON.tv interview at @DevOpsSummit (http://DevOpsSummit.SYS-CON.com), held June 9-11, 2015, at the Javits Center in New York
Jul. 6, 2015 03:45 PM EDT Reads: 1,715
"Plutora provides release and testing environment capabilities to the enterprise," explained Dalibor Siroky, Director and Co-founder of Plutora, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 6, 2015 03:00 PM EDT Reads: 1,757
DevOps tends to focus on the relationship between Dev and Ops, putting an emphasis on the ops and application infrastructure. But that’s changing with microservices architectures. In her session at DevOps Summit, Lori MacVittie, Evangelist for F5 Networks, will focus on how microservices are changing the underlying architectures needed to scale, secure and deliver applications based on highly distributed (micro) services and why that means an expansion into “the network” for DevOps.
Jul. 6, 2015 03:00 PM EDT Reads: 3,007
"The idea of polyglot persistence is you have to apply the right database for the job - you always have to have many different databases in play. We offer that whole system as a service," explained Raj Singh, Developer Advocate for IBM Cloud Data Services, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 6, 2015 03:00 PM EDT Reads: 625
In his session at 16th Cloud Expo, Simone Brunozzi, VP and Chief Technologist of Cloud Services at VMware, reviewed the changes that the cloud computing industry has gone through over the last five years and shared insights into what the next five will bring. He also chronicled the challenges enterprise companies are facing as they move to the public cloud. He delved into the "Hybrid Cloud" space and explained why every CIO should consider ‘hybrid cloud' as part of their future strategy to achie...
Jul. 6, 2015 03:00 PM EDT Reads: 1,740
SYS-CON Events announced today that WHOA.com, an ISO 27001 Certified secure cloud computing company, participated as “Bronze Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which took place June 9-11, 2015, at the Javits Center in New York City, NY. WHOA.com is a leader in next-generation, ISO 27001 Certified secure cloud solutions. WHOA.com offers a comprehensive portfolio of best-in-class cloud services for business including Infrastructure as a Service (IaaS), Secure Cloud Desk...
Jul. 6, 2015 02:45 PM EDT Reads: 859
SYS-CON Events announced today that Intelligent Systems Services will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Established in 1994, Intelligent Systems Services Inc. is located near Washington, DC, with representatives and partners nationwide. ISS’s well-established track record is based on the continuous pursuit of excellence in designing, implementing and supporting nationwide clients’ ...
Jul. 6, 2015 02:15 PM EDT Reads: 996
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of pro...
Jul. 6, 2015 02:15 PM EDT Reads: 1,831
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading in...
Jul. 6, 2015 02:00 PM EDT Reads: 1,249
SYS-CON Events announced today that MangoApps will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. MangoApps provides private all-in-one social intranets allowing workers to securely collaborate from anywhere in the world and from any device. Social, mobile, and easy to use. MangoApps has been named a "Market Leader" by Ovum Research and a "Cool Vendor" by Gartner. 20,000+ business custome...
Jul. 6, 2015 02:00 PM EDT Reads: 2,087
IT data is typically silo'd by the various tools in place. Unifying all the log, metric and event data in one analytics platform stops finger pointing and provides the end-to-end correlation. Logs, metrics and custom event data can be joined to tell the holistic story of your software and operations. For example, users can correlate code deploys to system performance to application error codes. In his session at DevOps Summit, Michael Demmer, VP of Engineering at Jut, will discuss how this can...
Jul. 6, 2015 02:00 PM EDT Reads: 1,377