Navigation Links
Amgen Receives CHMP Positive Opinion for XGEVA™ (Denosumab) in the European Union
Date:5/20/2011

ing the time until pain worsens.  XGEVA also offers the ease of every four weeks subcutaneous injection and no requirement for dose adjustment for changes in renal function. XGEVA has the potential to make a meaningful difference for patients with advanced cancer and their healthcare providers."

The CHMP positive opinion is based on three pivotal, Phase 3 head-to-head trials that evaluated the effectiveness of XGEVA versus Zometa® (zoledronic acid) at delaying SREs. The 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 Zometa.

Specifically, in patients with breast or prostate cancer and bone metastases, XGEVA was superior to Zometa in reducing the risk of SREs. In patients with bone metastases due to other solid tumors or multiple myeloma, XGEVA was non-inferior to Zometa in reducing the risk of SREs. In an integrated analysis of all three studies XGEVA was superior to Zometa in delaying time to first on-study SRE by 17 percent or 8.2 months (median time to first skeletal related event of 27.6 months for XGEVA and 19.4 months for Zometa, p <0.0001). In this analysis, XGEVA was also superior to Zometa in delaying time to first-and-subsequent on-study SRE by 18 percent (p<0.0001).

In patients with mild or no pain at baseline, time to worsening pain was delayed for XGEVA compared to Zometa (198 versus 143 days) (p=0.0002).  The time to pain improvement was similar for XGEVA and Zometa.

In these double-blind trials, XGEVA was administered every four weeks as a 120 mg subcutaneous injection, versus Zometa delivered every four weeks via a 15-minute intravenous infusion, with adjustments for kidney function per the requirements of the Zometa prescribing information. XGEVA was not associated with renal toxicity or acute phase reactions, both well known side effects of Zometa treatment. '/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Arthritis Foundation Announces Amgen and Wyeth to Be Presenting Sponsor of the 2008 Arthritis Walk (R)
2. Medarex to Receive Milestone Payment from Amgen
3. AMT Obtains License to Amgens GDNF Gene to Develop Treatment for Parkinsons Disease with AMTs Proprietary Gene Therapy Platform
4. Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer
5. CDC Foundation Partners with Amgen, CDC to Reduce Infections Among Cancer Patients
6. Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)
7. Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
8. Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events With Aranesp(R) Therapy (TREAT) in CKD Patients With Type-2 Diabetes
9. Amgen Presents Data From First Nplate(R) Study in Children With Chronic ITP
10. Amgen Highlights Data to be Presented at American Society for Bone and Mineral Research (ASBMR) Meeting
11. Amgen Board Authorizes $5 Billion Increase in Stock Repurchase Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2013)... May 21, 2013  NxStage Medical, Inc. (Nasdaq: ... products, today announced that it has entered into new ... in-center products to DaVita, the kidney care division of ... ) For the use of products for ... , NxStage has executed a second amended and restated ...
(Date:5/21/2013)... New data released today at the ... that the NeuroStar TMS Therapy System ® ... in patients with Major Depressive Disorder (MDD) during ... through one year of treatment.  At the end ... symptomatic improvement while 41 percent reported complete remission. ...
(Date:5/21/2013)... Quebec , May 21, 2013 ... (NYSE: VRX ) (TSX: ... ten directors nominated at its 2013 ... detailed results of the vote for ... out below:  NameForWithheldRonald H. Farmer235,731,9341,964,748Robert A. ...
Breaking Medicine Technology:NxStage Announces New Agreements with DaVita 2New Data Show Long-Term Benefit of Transcranial Magnetic Stimulation in Difficult-to-Treat Patients with Depression using NeuroStar TMS Therapy System 2New Data Show Long-Term Benefit of Transcranial Magnetic Stimulation in Difficult-to-Treat Patients with Depression using NeuroStar TMS Therapy System 3New Data Show Long-Term Benefit of Transcranial Magnetic Stimulation in Difficult-to-Treat Patients with Depression using NeuroStar TMS Therapy System 4Valeant Pharmaceuticals Announces 2013 Annual Meeting Results 2
... Astellas Pharma US, Inc. ("Astellas") recently hired Mark ... oncology. Reporting directly to Patrick Shea, senior vice ... responsible for all U.S. commercial activities supporting marketed ... lead commercial planning for early stage development compounds. ...
... The Targetech Innovation Center, supported by a strategic ... developing pipeline of biomedical device opportunities poised to begin ... "This is an exciting development in the strategic ... effort, we will see more companies locating to Akron. ...
Cached Medicine Technology:Astellas Announces Vice President of Sales and Marketing for U.S. Oncology Franchise 2Akron Relationship with Israeli Incubator, Targetech, Shows Promise 2Akron Relationship with Israeli Incubator, Targetech, Shows Promise 3
(Date:5/21/2013)... 2013 Phoseon Technology will present their ... 20th Annual IMI European Ink Jet Conference (June ... Phoseon continues to invest in product development to enable ... UV LED curing in printing applications. Phoseon currently ... market offering both air cooled and water cooled solutions ...
(Date:5/21/2013)... (PRWEB) May 21, 2013 Modern ... the help of Texas Counseling’s Sexuality and Relationship ... and the development of healthier habits for their ... available for both couples and individuals at Texas ... their relationships and learn skills to develop long ...
(Date:5/21/2013)... Repository (DoDSR), University of Cincinnati (UC) researchers have identified ... which could help with earlier diagnosis and intervention in ... finding, the first of its kind and led by ... presentation by staff from Walter Reed National Military Medical ... 18-21 in Orlando, Fla. , The DoDSR is ...
(Date:5/21/2013)... May 21, 2013 The Las Vegas personal ... to announce that Crawford Gates, a senior at Coronado High ... college scholarship essay contest . As the winner of the ... essay contest started on Dec. 1, 2012 and ran through ... to submit a three-page minimum essay on “The Role of ...
(Date:5/21/2013)... A new study appearing in the ... stem cells harvested from fat (adipose) are more potent ... modulate the body’s immune system. , The finding ... as adipose tissue-derived stem cells (AT-SCs) are far more ... marrow and can be collected from waste material from ...
Breaking Medicine News(10 mins):Health News:Workshops Offered To Identify Underlying Challenges That Put Strain On Relationships 2Health News:Biomarkers discovered for inflammatory bowel disease 2Health News:Benson, Bertoldo, Baker & Carter is Pleased to Announce the Winner of its First Annual College Scholarship Essay Contest 2Health News:Stem Cells from Fat Outperform Those from Bone Marrow in Fighting Disease 2Health News:Stem Cells from Fat Outperform Those from Bone Marrow in Fighting Disease 3
... fears associated ... with common diabetes complication, ALEXANDRIA, Va., Oct. 4 ... ghosts and,goblins. But for some, there is something that is ... is a diabetes complication for both men and women.,According to ...
... N.J., Oct. 4 The National Confectioner,s,Association has ... go trick-or-treating,this year. With this in mind, Halloween ... brushing habits to their children. "Since candy ... eating on Halloween. Kids can enjoy chocolate and,lollipops ...
... benefit management ... organizations, ST. ... pharmacy benefit management, announced today it has,achieved URAC Pharmacy Benefit Management ... encourage PBM,industry best practices, promote quality improvement and protect and,empower consumers. ...
... 3 The following is a,statement by Michael Bender, ... credit, the US Food and Drug Administration and its ... a considerable,number of years to present a balanced and ... They recognized that there is,there is enough mercury in ...
... 3 EpiCept Corporation,(Nasdaq and OMX Nordic Exchange: ... will be presenting at the 2007 BIO InvestorForum ... at the Palace Hotel in San,Francisco, California. Mr. ... http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO ) The presentation will ...
... be allergic to,work? If you experience symptoms of allergies ... asthma. This disorder is defined as,reversible airflow obstruction caused ... harmful substances while "on the,job," according to the American ... that about 15%, or 1 in 7, of adult ...
Cached Medicine News:Health News:Diabetes in the Bedroom: Scarier than Halloween? 2Health News:Parents can Help Young Superheroes Battle Cavities on Halloween Night 2Health News:Prime Therapeutics Announces URAC Accreditation 2Health News:New Fish Advice Throws Baby Out With the Bath Water, Says Mercury Watchdog Group 2Health News:EpiCept Corporation to Present at the 2007 BIO InvestorForum 2Health News:EpiCept Corporation to Present at the 2007 BIO InvestorForum 3Health News:AAAAI: Asthma on the Job 2Health News:AAAAI: Asthma on the Job 3
MT-BT-5011-25 Prostate seeding needle (set of 25 unloaded needles).,MT-BT-5011-P Prostate seeding needle, pre-plugged and pre-sterilized, unloaded or for use with MEDTECs ASAP™ pre-load seedin...
... offers five classes of resectoscope electrodes ... loops, knife, roller bar & ball, ... only electrodes specifically integrated into the ... removal with minimal bleeding, increased visibility, ...
... and MRO™-2005 Rigid Percutaneous Nephroscopes combine ... throughput capacity with proven MRO performance. ... with small size sheaths. The MRO™-20 ... easy positioning during percutaneous procedures. The ...
... Resectoscope is based on the award winning ... the surgeon to perform TURis - resection ... element, HF cable and electrodes, Olympus OES ... in saline, supporting both, standard TUR and ...
Medicine Products: