|By JCN Newswire||
|May 27, 2014 03:03 AM EDT||
Tokyo, May 27, 2014 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") announced today that its U.K. subsidiary Eisai Europe Limited has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on the indication expansion of Halaven (generic name: eribulin mesylate, "eribulin") to contribute to earlier-line treatment of patients with locally advanced or metastatic breast cancer 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.
Eribulin is currently indicated in Europe for the treatment of 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 an anthracycline and a taxane unless patients were not suitable for these treatments. The positive opinion received from the CHMP is a recommendation for the expansion of the current indication, which is limited to patients who have previously received at least two chemotherapeutic regimens, to include patients with metastatic breast cancer have had less prior treatment.
The CHMP's positive opinion is based on evidence from two pivotal Phase III studies, including the Phase III clinical study (Study 305: EMBRACE) of eribulin versus Treatment of Physician's Choice (TPC) in patients with locally advanced or metastatic breast cancer who had previously received at least two to five prior chemotherapeutic regimens including treatment with an anthracycline and a taxane, and a Phase III clinical study (Study 301) of eribulin versus capecitabine in women with locally advanced or metastatic breast cancer who had received prior treatment with an anthracycline and a taxane. These studies involved more than 1,800 patients, making this one of the largest data sets in metastatic breast cancer.
Although advances are being made in the treatment of breast cancer each year with the development of new diagnostic technologies and anticancer agents, the unmet medical needs of patients with metastatic breast cancer continue to remain high. Eisai remains committed to providing scientific evidence aimed at maximizing the value of Halaven as it seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, patients with cancer and their families as well as healthcare providers.
1. About Halaven (eribulin mesylate)
Halaven, a non-taxane, microtubule dynamics inhibitor with a novel mechanism of action, 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 sequestering tubulin into nonproductive aggregates. Halaven was first approved as a treatment for breast cancer in the United States in November 2010, and is approved in more than 50 countries worldwide, including European Union member states, Japan, Singapore and Switzerland. In Japan, the drug has been approved to treat inoperable or recurrent breast cancer and was launched in the country in July 2011. Furthermore, with the aim of maximizing value of the drug, Eisai is currently moving ahead with developments investigating the potential of Halaven as a therapy in the treatment of breast cancer with fewer prior treatments as well as soft-tissue sarcoma and non-small cell lung cancer.
2. About Study 305 (EMBRACE)
In the Phase III clinical study (Study 305, EMBRACE) of Halaven versus treatment of physician's choice (TPC) in 762 patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane, Halaven indicated extended overall survival (OS) of 2.5 months (OS of 13.1 months versus 10.6 months, respectively; Hazard Ratio (HR) 0.81; p=0.041) when compared to selected, major existing therapies. An updated analysis of OS (not protocol-specified) in the EMBRACE study was also performed at the request of European and U.S. regulatory authorities. These results demonstrated an increase of 2.7 months in OS for Halaven compared with TPC (OS of 13.2 months versus 10.5 months, respectively; HR 0.81; p=0.014). The most common adverse reactions (events with an incidence rate of at least 25%) among patients treated with Halaven were asthenia (fatigue), neutropenia, alopecia (hair loss), peripheral neuropathy (numbness and tingling in arms, legs and/or other parts of the body), nausea and constipation. The most common serious side effects reported in patients receiving Halaven were neutropenia. The most common adverse reaction resulting in discontinuation of treatment with Halaven was peripheral neuropathy (5%).
3. About Study 301
Study 301 was an open-label, randomized, two-parallel-arm, multicenter study designed to evaluate Halaven versus capecitabine in 1,102 women with locally advanced or metastatic breast cancer who had up to three prior chemotherapy regimens in the (neo)adjuvant setting, and no more than two prior regimens for locally advanced and/or metastatic disease. The regimens must have included an anthracycline and a taxane. Although eribulin did not achieve a statistically significant result when compared to capecitabine in terms of overall survival (OS) and progression-free survival (PFS), the co-primary endpoints of the study, eribulin did demonstrate a trend favoring improved OS (eribulin median OS: 15.9 months, capecitabine median OS: 14.5 months; HR 0.879; 95% CI: 0.770-1.003; p=0.056). Additionally, a later PFS assessment carried out by an independent evaluation body concluded that there was no significant difference between the two drugs (eribulin median PFS: 4.1 months, capecitabine median PFS: 4.2 months, HR 1.079; 95% CI: 0.932-1.250; p=0.305). In regard to safety, adverse events (AEs) were consistent with the known side-effect profiles of both drugs. The most common AEs (events with an incidence rate of at least 20%) for Halaven and capecitabine were, respectively, neutropenia (54.2% vs. 15.9%), hand-foot syndrome (0.2% vs. 45.1%), alopecia (34.6% vs. 4.0%), leukopenia (31.4% vs. 10.4%), diarrhea (14.3% vs. 28.8%), and nausea (22.2% vs. 24.4%).
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.
Public Relations Department, Eisai Co., Ltd. +81-3-3817-5120
Copyright 2014 JCN Newswire. All rights reserved. www.japancorp.net
SYS-CON Events announced today that IoT Now has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. IoT Now explores the evolving opportunities and challenges facing CSPs, and it passes on some lessons learned from those who have taken the first steps in next-gen IoT services.
Feb. 19, 2017 06:15 PM EST Reads: 913
SYS-CON Events announced today that WineSOFT will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Based in Seoul and Irvine, WineSOFT is an innovative software house focusing on internet infrastructure solutions. The venture started as a bootstrap start-up in 2010 by focusing on making the internet faster and more powerful. WineSOFT’s knowledge is based on the expertise of TCP/IP, VPN, SSL, peer-to-peer, mob...
Feb. 19, 2017 06:00 PM EST Reads: 1,217
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and containers together help companies achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of Dev...
Feb. 19, 2017 05:45 PM EST Reads: 5,180
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
Feb. 19, 2017 05:45 PM EST Reads: 761
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, discussed the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports.
Feb. 19, 2017 05:00 PM EST Reads: 755
The security needs of IoT environments require a strong, proven approach to maintain security, trust and privacy in their ecosystem. Assurance and protection of device identity, secure data encryption and authentication are the key security challenges organizations are trying to address when integrating IoT devices. This holds true for IoT applications in a wide range of industries, for example, healthcare, consumer devices, and manufacturing. In his session at @ThingsExpo, Lancen LaChance, vic...
Feb. 19, 2017 05:00 PM EST Reads: 7,978
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
Feb. 19, 2017 05:00 PM EST Reads: 1,440
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Feb. 19, 2017 05:00 PM EST Reads: 7,875
SYS-CON Events announced today that Dataloop.IO, an innovator in cloud IT-monitoring whose products help organizations save time and money, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Dataloop.IO is an emerging software company on the cutting edge of major IT-infrastructure trends including cloud computing and microservices. The company, founded in the UK but now based in San Fran...
Feb. 19, 2017 04:15 PM EST Reads: 1,898
Building a cross-cloud operational model can be a daunting task. Per-cloud silos are not the answer, but neither is a fully generic abstraction plane that strips out capabilities unique to a particular provider. In his session at 20th Cloud Expo, Chris Wolf, VP & Chief Technology Officer, Global Field & Industry at VMware, will discuss how successful organizations approach cloud operations and management, with insights into where operations should be centralized and when it’s best to decentraliz...
Feb. 19, 2017 03:45 PM EST Reads: 1,246
In the first article of this three-part series on hybrid cloud security, we discussed the Shared Responsibility Model and examined how the most common attack strategies persist, are amplified, or are mitigated as assets move from data centers to the cloud. Today, we’ll look at some of the unique security challenges that are introduced by public cloud environments. While cloud computing delivers many operational, cost-saving and security benefits, it takes place in a public, shared and on-demand ...
Feb. 19, 2017 02:45 PM EST Reads: 875
In his session at @ThingsExpo, Sudarshan Krishnamurthi, a Senior Manager, Business Strategy, at Cisco Systems, will discuss how IT and operational technology (OT) work together, as opposed to being in separate siloes as once was traditional. Attendees will learn how to fully leverage the power of IoT in their organization by bringing the two sides together and bridging the communication gap. He will also look at what good leadership must entail in order to accomplish this, and how IT managers ca...
Feb. 19, 2017 02:30 PM EST Reads: 1,038
In his session at 20th Cloud Expo, Mike Johnston, an infrastructure engineer at Supergiant.io, will discuss how to use Kubernetes to setup a SaaS infrastructure for your business. Mike Johnston is an infrastructure engineer at Supergiant.io with over 12 years of experience designing, deploying, and maintaining server and workstation infrastructure at all scales. He has experience with brick and mortar data centers as well as cloud providers like Digital Ocean, Amazon Web Services, and Rackspace....
Feb. 19, 2017 02:30 PM EST Reads: 2,064
The financial services market is one of the most data-driven industries in the world, yet it’s bogged down by legacy CPU technologies that simply can’t keep up with the task of querying and visualizing billions of records. In his session at 20th Cloud Expo, Jared Parker, Director of Financial Services at Kinetica, will discuss how the advent of advanced in-database analytics on the GPU makes it possible to run sophisticated data science workloads on the same database that is housing the rich inf...
Feb. 19, 2017 02:15 PM EST Reads: 897
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Feb. 19, 2017 02:00 PM EST Reads: 877