Welcome!

News Feed Item

Astellas Announces Marketing Authorisation Application for XTANDI™ (enzalutamide) for Chemotherapy-Naïve Metastatic Prostate Cancer

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.

About XTANDI 

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:

http://www.medicines.org.uk/emc/medicine/27912/SPC/Xtandi+40mg+soft+capsules/

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

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
In his session at 21st Cloud Expo, Raju Shreewastava, founder of Big Data Trunk, will provide a fun and simple way to introduce Machine Leaning to anyone and everyone. Together we will solve a machine learning problem and find an easy way to be able to do machine learning without even coding. Raju Shreewastava is the founder of Big Data Trunk (www.BigDataTrunk.com), a Big Data Training and consulting firm with offices in the United States. He previously led the data warehouse/business intellige...
Gemini is Yahoo’s native and search advertising platform. To ensure the quality of a complex distributed system that spans multiple products and components and across various desktop websites and mobile app and web experiences – both Yahoo owned and operated and third-party syndication (supply), with complex interaction with more than a billion users and numerous advertisers globally (demand) – it becomes imperative to automate a set of end-to-end tests 24x7 to detect bugs and regression. In th...
As popularity of the smart home is growing and continues to go mainstream, technological factors play a greater role. The IoT protocol houses the interoperability battery consumption, security, and configuration of a smart home device, and it can be difficult for companies to choose the right kind for their product. For both DIY and professionally installed smart homes, developers need to consider each of these elements for their product to be successful in the market and current smart homes.
Infoblox delivers Actionable Network Intelligence to enterprise, government, and service provider customers around the world. They are the industry leader in DNS, DHCP, and IP address management, the category known as DDI. We empower thousands of organizations to control and secure their networks from the core-enabling them to increase efficiency and visibility, improve customer service, and meet compliance requirements.
In his session at 21st Cloud Expo, Michael Burley, a Senior Business Development Executive in IT Services at NetApp, will describe how NetApp designed a three-year program of work to migrate 25PB of a major telco's enterprise data to a new STaaS platform, and then secured a long-term contract to manage and operate the platform. This significant program blended the best of NetApp’s solutions and services capabilities to enable this telco’s successful adoption of private cloud storage and launchi...
The session is centered around the tracing of systems on cloud using technologies like ebpf. The goal is to talk about what this technology is all about and what purpose it serves. In his session at 21st Cloud Expo, Shashank Jain, Development Architect at SAP, will touch upon concepts of observability in the cloud and also some of the challenges we have. Generally most cloud-based monitoring tools capture details at a very granular level. To troubleshoot problems this might not be good enough.
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In their Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, and Mark Lav...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend 21st Cloud Expo October 31 - November 2, 2017, at the Santa Clara Convention Center, CA, and June 12-14, 2018, at the Javits Center in New York City, NY, and learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
Cloud Expo, Inc. has announced today that Andi Mann and Aruna Ravichandran have been named Co-Chairs of @DevOpsSummit at Cloud Expo Silicon Valley which will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. "DevOps is at the intersection of technology and business-optimizing tools, organizations and processes to bring measurable improvements in productivity and profitability," said Aruna Ravichandran, vice president, DevOps product and solutions marketing...
Smart cities have the potential to change our lives at so many levels for citizens: less pollution, reduced parking obstacles, better health, education and more energy savings. Real-time data streaming and the Internet of Things (IoT) possess the power to turn this vision into a reality. However, most organizations today are building their data infrastructure to focus solely on addressing immediate business needs vs. a platform capable of quickly adapting emerging technologies to address future ...
SYS-CON Events announced today that mruby Forum will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. mruby is the lightweight implementation of the Ruby language. We introduce mruby and the mruby IoT framework that enhances development productivity. For more information, visit http://forum.mruby.org/.
The dynamic nature of the cloud means that change is a constant when it comes to modern cloud-based infrastructure. Delivering modern applications to end users, therefore, is a constantly shifting challenge. Delivery automation helps IT Ops teams ensure that apps are providing an optimal end user experience over hybrid-cloud and multi-cloud environments, no matter what the current state of the infrastructure is. To employ a delivery automation strategy that reflects your business rules, making r...
Digital transformation is changing the face of business. The IDC predicts that enterprises will commit to a massive new scale of digital transformation, to stake out leadership positions in the "digital transformation economy." Accordingly, attendees at the upcoming Cloud Expo | @ThingsExpo at the Santa Clara Convention Center in Santa Clara, CA, Oct 31-Nov 2, will find fresh new content in a new track called Enterprise Cloud & Digital Transformation.
Most technology leaders, contemporary and from the hardware era, are reshaping their businesses to do software. They hope to capture value from emerging technologies such as IoT, SDN, and AI. Ultimately, irrespective of the vertical, it is about deriving value from independent software applications participating in an ecosystem as one comprehensive solution. In his session at @ThingsExpo, Kausik Sridhar, founder and CTO of Pulzze Systems, will discuss how given the magnitude of today's applicati...