Navigation Links
XGEVA® (Denosumab) Granted Marketing Authorization in the European Union
Date:7/15/2011

THOUSAND OAKS, Calif., July 15, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the European Commission (EC) has granted marketing authorization for XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors. This approval of XGEVA applies to all 27 European Union (EU) member states. The EC also granted XGEVA an additional year of data and market exclusivity in the EU since the indication was considered new for denosumab and based on the significant clinical benefit of XGEVA in comparison with existing therapies.

Bone metastases, the spread of cancer to the bones, are a common and serious concern for patients with advanced cancer and present a burden to the healthcare system. Weakened bones due to metastases can lead to SREs. The primary goal of treatment for bone metastases is to prevent the occurrence of these debilitating and costly SREs.

"Skeletal-related events associated with bone metastases are truly devastating and painful for patients living with cancer, and today's approval of XGEVA marks a real advance," said Professor Ingo J. Diel, M.D., Institute for Gynecological Oncology, SPGO, Mannheim, Germany. "In clinical trials XGEVA demonstrated sustained protection from SREs and also delayed the progression of pain. These factors will make a genuine difference in the lives of patients living with advanced cancer."

The marketing authorization for XGEVA is based on three pivotal, Phase 3 head-to-head trials that evaluated the effectiveness of XGEVA versus zoledronic acid at delaying SREs. The SRE clinical program for XGEVA spanned more than 50 tumor types in over 5,700 patients. In the SRE trials, XGEVA demonstrated a clinically meaningful improvement in preventing SREs compared to zoledronic acid. In these trials, XGEVA was administered every four weeks as a 120 mg subcu
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Amgen Receives CHMP Positive Opinion for XGEVA™ (Denosumab) in the European Union
2. Treatment With Prolia® (denosumab) Associated With Significantly Greater Adherence, Compliance and Persistence Compared to Alendronate
3. Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment With Similar Safety Profile Observed in Pivotal Trial
4. Results Published in The Lancet Demonstrate Superiority of XGEVA™ (Denosumab) in the Prevention of Bone Complications for Men With Bone Metastases From Advanced Prostate Cancer
5. The Journal of Clinical Oncology Publishes Phase 3 XGEVA™ (Denosumab) Results in Advanced Cancer Patients With Solid Tumors or Multiple Myeloma
6. XGEVA™ (Denosumab) Significantly Improved Bone Metastasis-Free Survival in Men With Prostate Cancer
7. Amgen Presents New XGEVA™ (Denosumab) Breast Cancer Skeletal-Related Event Prevention Data at SABCS
8. Prolia™ (denosumab) Receives Best New Drug Honor at Scrip Awards
9. China Botanic Pharmaceutical Granted China Patent for Siberian Ginseng Extraction Process
10. ACT Granted EU Orphan Medicinal Product Designation for hESC-Derived RPE Cells for Treatment of Stargardts Disease
11. ViroPharmas Cinryze® (C1 Inhibitor [Human]) Granted European Marketing Authorization for Hereditary Angioedema (HAE)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/22/2014)... July 22, 2014 BioDelivery Sciences International, Inc. ... Board of Directors has appointed Charles J. (Chuck) ... as members of the Board.  Mr. ... experience in marketing, sales and other commercial functions.  He ... Inc., a development stage company that was recently acquired ...
(Date:7/22/2014)... , July 22, 2014  NeuroSigma, Inc. (NeuroSigma), a ... on commercialization of its non-invasive Monarch ™ ... neuropsychiatric disorders, today announced that enrollment has begun in ... stimulation (eTNS) as adjunctive therapy for the treatment of ... conducted at the Olive View-UCLA Medical Center in ...
(Date:7/21/2014)... ANGELES , July 21, 2014 /PRNewswire-iReach/ -- Nitrosolution.com, ... oxide supplements , will celebrate its first anniversary in ... that is designed to enhance the body,s ability to ... formula that is made up of a variety of ... said have been found to increase nitric oxide ...
Breaking Medicine Technology:BioDelivery Sciences Appoints Charles J. Bramlage and Dr. Barry I. Feinberg to its Board of Directors 2BioDelivery Sciences Appoints Charles J. Bramlage and Dr. Barry I. Feinberg to its Board of Directors 3BioDelivery Sciences Appoints Charles J. Bramlage and Dr. Barry I. Feinberg to its Board of Directors 4BioDelivery Sciences Appoints Charles J. Bramlage and Dr. Barry I. Feinberg to its Board of Directors 5BioDelivery Sciences Appoints Charles J. Bramlage and Dr. Barry I. Feinberg to its Board of Directors 6BioDelivery Sciences Appoints Charles J. Bramlage and Dr. Barry I. Feinberg to its Board of Directors 7Enrollment Commences in NeuroSigma-Sponsored Pediatric Clinical Trial for the Treatment of Lennox-Gastaut Syndrome 2Enrollment Commences in NeuroSigma-Sponsored Pediatric Clinical Trial for the Treatment of Lennox-Gastaut Syndrome 3Enrollment Commences in NeuroSigma-Sponsored Pediatric Clinical Trial for the Treatment of Lennox-Gastaut Syndrome 4Enrollment Commences in NeuroSigma-Sponsored Pediatric Clinical Trial for the Treatment of Lennox-Gastaut Syndrome 5Up and Coming Nitric Oxide Supplements Company Nitrosolution.com Celebrates its One Year Anniversary 2
... -First Combination Study of a MET and EGFR Inhibitor-, ... (Nasdaq: EXEL ) today announced that it has ... non-small cell lung cancer (NSCLC) who have had,progressive disease ... a small molecule that simultaneously inhibits the MET, RET ...
... ASHBURN, Va., Jan. 4 Innocoll, Inc., ... first of a series of,planned phase 2 ... subsidiary,Innocoll Technologies Ltd, to investigate CollaRx(R) BUPIVACAINE ... has commenced dosing., Innocoll,s BUPIVACAINE SURGICAL ...
Cached Medicine Technology:Exelixis Initiates Phase 1/2 Trial of XL184 in Patients With Non-Small Cell Lung Cancer 2Exelixis Initiates Phase 1/2 Trial of XL184 in Patients With Non-Small Cell Lung Cancer 3Exelixis Initiates Phase 1/2 Trial of XL184 in Patients With Non-Small Cell Lung Cancer 4Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-operative Pain 2Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-operative Pain 3Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-operative Pain 4
(Date:7/22/2014)... July 22, 2014 According to a ... care, Automobile, Aerospace & Defense, Marine and Mining) & ... East, and Rest of the world) - Forecast Analysis ... expected to grow at a CAGR 8.00% to reach ... is estimated to grow at a CAGR of 6.00% ...
(Date:7/22/2014)... Carlsbad, CA (PRWEB) July 22, 2014 ... 0% financing for 24 months on all models during ... 18th-28th. , Please visit http://www.d1spas.com/financing for ... leader in hydrotherapy, Dimension One Spas offers a wide ... your fingertips including lights, fountains, waterfalls, music, customizable massage, ...
(Date:7/22/2014)... -- People who suffer long-term sleep problems after a ... pressure, a new study suggests. Previous research has ... death, but few studies have examined the reasons for ... causes, according to the University of Arizona investigators. ... or divorced for about 16 weeks. They reported on ...
(Date:7/22/2014)... a five-year, $3 million grant to study how ... maltreatment during childhood leave molecular marks in DNA ... The Center for Biomarker Research and Personalized Medicine ... with Duke University School of Medicine, will conduct ... National Institutes of Health, National Institute of Mental ...
(Date:7/22/2014)... Belmont, CA (PRWEB) July 22, 2014 ... and publisher for women, this year celebrates its tenth ... Silicon Valley. Thousands of attendees, including community leaders from ... sponsoring brands representing every consumer vertical, will converge in ... cutting edge conversation, and a “selfiebration” of social technology. ...
Breaking Medicine News(10 mins):Health News:Global Actuators Market Estimated to Reach $59.32 Billion by 2019 – New Report by MarketsandMarkets 2Health News:Global Actuators Market Estimated to Reach $59.32 Billion by 2019 – New Report by MarketsandMarkets 3Health News:Global Actuators Market Estimated to Reach $59.32 Billion by 2019 – New Report by MarketsandMarkets 4Health News:Sleepless Nights After Divorce May Be Tied to Blood Pressure Rise 2Health News:VCU receives grant to study molecular marks left by childhood adverse experiences 2Health News:BlogHer, Inc. Comes Home to Silicon Valley for 10th Anniversary: World’s Largest Event for Bloggers and Social Media Influencers 2Health News:BlogHer, Inc. Comes Home to Silicon Valley for 10th Anniversary: World’s Largest Event for Bloggers and Social Media Influencers 3Health News:BlogHer, Inc. Comes Home to Silicon Valley for 10th Anniversary: World’s Largest Event for Bloggers and Social Media Influencers 4
... 8 A woman in the United,States is ... finding,breast cancer at an early stage greatly improves ... most important woman in all our lives, our,mothers, ... celebrating,Mother,s Day by involving the culinary community and ...
... Hospital buildings can heal,according to the first ... the,physical environment on child patients in health care ... through the,Physical Environment is produced by the National ... partnership with the Center,for Health Design. Findings from ...
... 7 As the result of San ... chapters, the,North-American Interfraternity Conference supports the decisions ... officials to hold those,responsible parties accountable for ... will continue to collaborate with our member ...
... May 7 The top of the Empire State ... Picchu. James Chippendale is a,leukemia survivor and co-founder of ... concerts in high locations to,raise funds for cancer centers ... with a very aggressive form of,leukemia. His doctors gave ...
... 7 Oracle Healthcare,Acquisition Corp. (the "Company") (OTC ... approve the dissolution of the Company and,its proposed ... proxy,statement dated April 16, 2008, at the special ... As previously announced, the Company has set May ...
... COLUMBIA, Mo. Telehealth, using telecommunication technology to ... improve the delivery and availability of health care ... found that patients who received a telehealth intervention ... rates when compared to patients who received traditional ...
Cached Medicine News:Health News:Celebrity Chefs and America's Restaurants Cook for the Cure This Mother's Day 2Health News:Celebrity Chefs and America's Restaurants Cook for the Cure This Mother's Day 3Health News:Hospital Buildings Can Heal According to First Comprehensive Report on Impact of Physical Environment on Child Patients 2Health News:Hospital Buildings Can Heal According to First Comprehensive Report on Impact of Physical Environment on Child Patients 3Health News:Hospital Buildings Can Heal According to First Comprehensive Report on Impact of Physical Environment on Child Patients 4Health News:James Chippendale Climbs the Mountain of Life 2Health News:Oracle Healthcare Acquisition Corp. Announces Stockholder Approval of Proposed Dissolution and Plan of Liquidation 2Health News:Patients with chronic illness benefit from telehealth intervention 2