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

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:7/30/2015)... , July 30, 2015  Tandem Diabetes Care®, ... company and manufacturer of the t:slim® and t:flex™ ... into non-exclusive Development Agreements with Dexcom, Inc. to ... pumps with the Dexcom G5 and G6 continuous ... next generation pump platform with Dexcom,s future CGM ...
(Date:7/30/2015)...  Amgen (NASDAQ: AMGN ) today announced ... Key results include: , Total revenues increased ... to $5,370 million, with 6 percent product sales ... Prolia ® (denosumab), Sensipar ® (cinacalcet), ... (denosumab). Unfavorable changes in foreign exchange rates impacted ...
(Date:7/30/2015)... 30, 2015 Eisai Inc. announced today that ... United States , European Union and ... respectively) for eribulin, for the treatment of patients with ... chemotherapy for advanced or metastatic disease. ... pivotal global Phase 3 clinical trial (Study 309), which ...
Breaking Medicine Technology:Tandem Diabetes Care Announces Development Agreement with Dexcom for Integration of Future Generation CGM Systems 2Tandem Diabetes Care Announces Development Agreement with Dexcom for Integration of Future Generation CGM Systems 3Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 2Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 3Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 4Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 5Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 6Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 7Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 8Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 9Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 10Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 11Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 12Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 13Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 14Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 15Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 16Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 17Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 18Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 19Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 20Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 21Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 22Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 23Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 2Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 3Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 4Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 5
... July 27, 2011 Reportlinker.com announces that ... in its catalogue: India ... Till 2016 http://www.reportlinker.com/p0575381/India-Cardiac-Catheters-and-Guidewires---Market-Trends-Till-2016.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Surgical_Equipment ... This market report provides vital ...
... 26, 2011 Symmetry Medical Inc. (NYSE: SMA ... orthopaedic device industry and other medical markets, announced today that ... period ending July 2, 2011 before the market opens on ... conference call at 8:00 a.m. ET on Thursday, August 4, ...
Cached Medicine Technology:India Cardiac Catheters and Guidewires - Market Trends Till 2016 2India Cardiac Catheters and Guidewires - Market Trends Till 2016 3Symmetry Medical to Report Second Quarter 2011 Financial Results on August 4, 2011 2
(Date:7/31/2015)... (PRWEB) , ... July 31, 2015 , ... ... of All Types " from NBC talked about a woman’s unfortunate experience having ... performed sclerotherapy on her face, which resulted in blistering, swelling, bruising, and pain. ...
(Date:7/31/2015)... ... July 31, 2015 , ... In the most recent testosterone lawsuit ... the Northern District of Illinois, Androgel testosterone attorneys report that a “Mini Status Conference” ... was made recording the minutes of the status conference, which was held that day, ...
(Date:7/31/2015)... (PRWEB) , ... July 31, 2015 , ... India ... United States for temporary work, study or family visit for the past 25 years. ... 80s and 90s are able to travel and spend time with their children and ...
(Date:7/31/2015)... , ... July 31, 2015 , ... ... launched a Balloon Sinuplasty website to inform potential Nashville area sinus sufferers ... that can be used to determine if someone is a good candidate for ...
(Date:7/30/2015)... ... July 30, 2015 , ... Dale Sky Jones, Executive Chancellor of Oaksterdam ... International Cannabis Professionals Expo held at the Caribe Royal All Suites Hotel and Convention ... Expo is the largest medical cannabis expo in the country and this year’s ...
Breaking Medicine News(10 mins):Health News:Dermatologists Discuss Rise in Unqualified Practitioners of Cosmetic Dermatology 2Health News:Dermatologists Discuss Rise in Unqualified Practitioners of Cosmetic Dermatology 3Health News:Testosterone Lawsuit News: Androgel Lawsuit Conference Held 2Health News:Testosterone Lawsuit News: Androgel Lawsuit Conference Held 3Health News:Testosterone Lawsuit News: Androgel Lawsuit Conference Held 4Health News:India Network Visitor Health Insurance Announces Completion of Food Grains Distribution to Godavari Pushkaram Visitors, Andhra Pradesh, India 2Health News:India Network Visitor Health Insurance Announces Completion of Food Grains Distribution to Godavari Pushkaram Visitors, Andhra Pradesh, India 3Health News:Nashville Otolaryngologist Dr. David Gilpin Launches Balloon Sinuplasty Website 2Health News:Nashville Otolaryngologist Dr. David Gilpin Launches Balloon Sinuplasty Website 3Health News:Finally…First Ever Professional Training Event for Doctors and Nurses Wanting to Offer Medical Marijuana Recommendations to Patients 2Health News:Finally…First Ever Professional Training Event for Doctors and Nurses Wanting to Offer Medical Marijuana Recommendations to Patients 3Health News:Finally…First Ever Professional Training Event for Doctors and Nurses Wanting to Offer Medical Marijuana Recommendations to Patients 4Health News:Finally…First Ever Professional Training Event for Doctors and Nurses Wanting to Offer Medical Marijuana Recommendations to Patients 5
... by preventing disease have been around for centuries. Now, ... how they will be combined with existing treatments is ... Michigan Health System recommend that a national strategy be ... so that cancers with less effective treatment options are ...
... has long been known that getting enough vitamin D is key ... issue, experts say. According to the Endocrine Society, very few ... is one of the best sources of the nutrient. People ... phosphorus and bone metabolism abnormalities, which can lead to a number ...
... that there can be a significantly higher risk of ... shingles, or herpes zoster, attack. The findings, which support ... published in The Journal of Infectious Diseases ... MS is an autoimmune disease that affects the brain ...
... in the current issue of Technology & Innovation, ... reports on the bright future and enormous need for ... suffering from debilitating and deadly diseases. ... therapy through "simple cell replacement" procedures to restructure damaged ...
... , When a person has a family history of cancer, ... refusing to have preventive tests. Advice from genetic counselling units ... Now, a scientific team has validated the ,Escala de Preocupacin ... Scale), the first of its kind in the Spanish language, ...
... Black and other minority children in the United States spend ... listening to music, using computers and playing video games, new ... previous media use studies done by the Kaiser Family Foundation ... consume an average of 13 hours of media content a ...
Cached Medicine News:Health News:U-M researchers advocate national strategic approach to therapeutic cancer vaccines 2Health News:New Guidelines Put Focus on Vitamin D Deficiency 2Health News:Study finds shingles may be related to elevated risk of multiple sclerosis 2Health News:The future of stem cell applications challenging, bright 2Health News:Scale helps to measure the utility of genetic counseling in tackling fear of cancer 2Health News:Greater Media Use Found Among Minority Kids 2
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: