|By PR Newswire||
|April 3, 2014 03:04 AM EDT||
TOKYO, April 3, 2014 /PRNewswire/ --
Astellas Pharma Inc. (TSE:4503) today announces the submission of a variation to amend the Marketing Authorisation Application for XTANDI™ (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.Enzalutamide is currently approved in Europe for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel chemotherapy.[i]
This announcement follows presentation of the Phase III data for the PREVAIL trial at the American Society of Clinical Oncology (ASCO) 2014 Genitourinary (GU) Cancers Symposium in San Francisco on Thursday, January 30, 2014.[ii]
In the Phase III PREVAIL trial, treatment with enzalutamide showed a statistically significant overall survival benefit compared with placebo, with enzalutamide reducing the risk of death by 29% (HR=0.71; p<0.0001), compared with placebo.[ii] Treatment with enzalutamide also significantly reduced the risk of radiographic progression or death by 81% compared with placebo treatment (HR=0.19; p<0.0001).[ii] Men taking enzalutamide experienced a 17-month delay in the time to initiation of chemotherapy compared with men taking placebo (28.0 months versus 10.8 months; HR=0.35; p<0.0001).[ii]The study also concluded that enzalutamide was generally well tolerated by patients and met all secondary endpoints.[ii]
Prostate cancer is the most common cancer in men in Europe, accounting for over 20% of all cancer diagnoses (excluding non-melanoma skin cancer) and is the third most common cause of cancer death in Europe.[iii] Up to 40% of men with prostate cancer develop metastatic disease and a high number of these men eventually fail androgen deprivation treatment, which is called castration-resistant prostate cancer (CRPC).[iv]
"Oncology is a growing area of focus for Astellas, and we are committed to developing and bringing to market medicines which meet current unmet medical needs," said Dr Ayad Abdulahad, Senior Vice President, Medical Affairs & Health Economics, Astellas Pharma Europe Ltd. "We will continue to work with our partner, Medivation, to seek the necessary European regulatory approval for Xtandi, that will allow for its use amongst patients who have not received chemotherapy for their advanced prostate cancer."
About the PREVAIL Trial
The Phase 3 PREVAIL trial is a randomized, double-blind, placebo-controlled, multi-national trial that enrolled more than 1,700 patients at sites in the United States, Canada, Europe, Australia, Russia, Israel and Asian countries including Japan. The trial enrolled patients with chemotherapy-naïve metastatic prostate cancer whose disease progressed on a luteinizing hormone-releasing hormone analogue or after bilateral orchiectomy. The co-primary endpoints of the trial were overall survival and radiographic progression-free survival. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily versus placebo.
Xtandi is a novel, oral, once-daily androgen receptor signalling inhibitor. Xtandi directly targets the androgen receptors (AR) and exerts its effects on all three steps of AR signalling pathway:
- Blocks androgen binding[v]
- Androgen binding induces a conformational change that triggers activation of the receptor[vi]
- Prevents nuclear translocation[v]
- Transit of the AR to the nucleus is an essential step in AR-mediated gene regulation[vi]
- Impairs DNA binding[v]
- Binding of the AR to the DNA is essential for modulation of gene expression[vi]
Xtandi was approved by the FDA on August 31, 2012 and is indicated for the treatment of adult men with mCRPC who have previously received docetaxel[vii]
Xtandi is currently licensed in Europe for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy.[i] Marketing authorisation was granted by the European Commission on June 21, 2013.
In March 2014, Astellas and Medivation submitted a supplemental new drug application for Xtandi for chemotherapy-naïve advanced prostate cancer to the US Food and Drug Administration.
Important Safety Information for XTANDI™
For important Safety Information for Xtandi please see the full Summary of Product Characteristics at:
About Astellas Pharma Inc.
Astellas Pharma Inc. is a pharmaceutical company dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. The organisation is committed to being a global category leader in Oncology and Urology, and has several oncology compounds in development in addition to enzalutamide. For more information on Astellas Pharma Inc., please visit our website at http://www.astellas.com/en.
About the Astellas / Medivation Collaboration
In October 2009, Medivation and Astellas entered into a global agreement to jointly develop and commercialize enzalutamide. The companies are collaborating on a comprehensive development program that includes studies to develop enzalutamide across the full spectrum of advanced prostate cancer as well as advanced breast cancer. The companies jointly commercialize Xtandi in the United States and Astellas will have responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing Xtandi outside the United States.
i. European Medicines Agency, XTANDI, (enzalutamide) Summary of Product Characteristics, 2013
ii. Beer T, et al. Enzalutamide Decreases Risk of Death and Delays Progression in Phase 3 Trial of Men with Metastatic Prostate Cancer. Presentation ASCO GU 2014
iii. Ferlay J, Shin HR, Bray F et al. Globocan 2008 v2.0, cancer incidence and mortality worldwide. IARC CancerBase No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer 2010. Available from: http://globocan.iarc.fr. Last accessed March 2014
iv. Beltran H, Beer TM, Carducci MA et al. New therapies for castration-resistant prostate cancer: Efficacy and safety. Eur Urol 2011; 60 (2): 279-290
v. Tran C, et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science 2009;324:787-790
vi. Hu R, Denmeade SR and Luo J. Molecular processes leading to aberrant androgen receptor signaling and castration resistance in prostate cancer. Expert Rev Endocrinol Metab 2010; 5 (5): 753-764
vii. U.S. Food and Drug Administration. Enzalutamide (XTANDI Capsules). Available from: http://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm317997.htm. Last accessed March 2014
Information technology (IT) advances are transforming the way we innovate in business, thereby disrupting the old guard and their predictable status-quo. It’s creating global market turbulence. Industries are converging, and new opportunities and threats are emerging, like never before. So, how are savvy chief information officers (CIOs) leading this transition? Back in 2015, the IBM Institute for Business Value conducted a market study that included the findings from over 1,800 CIO interviews ...
Feb. 24, 2017 01:15 AM EST Reads: 1,881
IoT is at the core or many Digital Transformation initiatives with the goal of re-inventing a company's business model. We all agree that collecting relevant IoT data will result in massive amounts of data needing to be stored. However, with the rapid development of IoT devices and ongoing business model transformation, we are not able to predict the volume and growth of IoT data. And with the lack of IoT history, traditional methods of IT and infrastructure planning based on the past do not app...
Feb. 24, 2017 01:00 AM EST Reads: 1,876
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Feb. 24, 2017 01:00 AM EST Reads: 2,524
Niagara Networks exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
Feb. 24, 2017 12:45 AM EST Reads: 955
WebRTC services have already permeated corporate communications in the form of videoconferencing solutions. However, WebRTC has the potential of going beyond and catalyzing a new class of services providing more than calls with capabilities such as mass-scale real-time media broadcasting, enriched and augmented video, person-to-machine and machine-to-machine communications. In his session at @ThingsExpo, Luis Lopez, CEO of Kurento, introduced the technologies required for implementing these idea...
Feb. 23, 2017 11:30 PM EST Reads: 6,285
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Feb. 23, 2017 11:00 PM EST Reads: 7,005
Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing and analyzing streaming data is the Lambda Architecture, represent...
Feb. 23, 2017 10:00 PM EST Reads: 4,595
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. 23, 2017 09:15 PM EST Reads: 1,509
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
Feb. 23, 2017 08:45 PM EST Reads: 1,289
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. 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 June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Feb. 23, 2017 08:30 PM EST Reads: 1,447
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...
Feb. 23, 2017 08:15 PM EST Reads: 8,022
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and sh...
Feb. 23, 2017 07:45 PM EST Reads: 3,377
FinTech is the sum of financial and technology, and it’s one of the fastest growing tech industries. Total global investments in FinTech almost reached $50 billion last year, but there is still a great deal of confusion over what it is and what it means – especially as it applies to retirement. Building financial startups is not simple, but with the right team, technology and an innovative approach it can be an extremely interesting domain to disrupt. FinTech heralds a financial revolution that...
Feb. 23, 2017 07:30 PM EST Reads: 1,743
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. 23, 2017 06:45 PM EST Reads: 1,450
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
Feb. 23, 2017 06:30 PM EST Reads: 6,293