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:3/27/2015)... 27, 2015  Victoria Vein & Surgery Clinic is the ... Duality laser in Victoria, Texas . The ... as advanced laser treatments for a variety of medical and ... to provide more services for their patients. Since adding laser ... Victoria residents get rid of their unwanted ...
(Date:3/27/2015)... , March 27, 2015 Zimmer Holdings, Inc. (NYSE and ... NexGen ® Complete Knee System. ... the 20 th year since Zimmer first introduced the NexGen ... market. To date, more than five million implantations of the NexGen ... history of the NexGen knee demonstrates the importance of design ...
(Date:3/27/2015)... LONDON , March 27, 2015 ... commercial prospects for leading ophthalmic drug companies  ... the pharma ophthalmic industry ? Visiongain,s brand new ... trends, opportunities and prospects there. Our 242-page ... most lucrative areas in the industry and the future ...
Breaking Medicine Technology:Victoria Vein And Surgery Clinic Uses Advanced Astanza Duality Tattoo Removal Technology 2Zimmer Celebrates Key Milestones For NexGen Complete Knee System 2Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2015-2025 2Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2015-2025 3Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2015-2025 4Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2015-2025 5Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2015-2025 6Pharma Leader Series: Top 25 Ophthalmic Drug Manufacturers 2015-2025 7
... Calif., Nov. 17, 2011 BioMarin Pharmaceutical Inc. (Nasdaq: ... Development Day for the investment community on Thursday, December ... the Four Seasons Hotel in New York City.  Members ... an update on the company,s product portfolio and advancements ...
... 2011 Global performance improvement solutions provider General ... Strategies Corporation (NYSE: GPX ), announced today ... (Seville, Spain), a leading European ... facilities with advanced combustion control technologies to optimize fuel ...
Cached Medicine Technology:BioMarin to Host a Research and Development Day on December 8th 2GP and INERCO Form Strategic Alliance to Assist Clients with Optimizing Fuel Costs and Decreasing Emissions 2GP and INERCO Form Strategic Alliance to Assist Clients with Optimizing Fuel Costs and Decreasing Emissions 3
(Date:3/28/2015)... How best to treat and recover ... orthopaedic medicine. While diagnostic hip injections are commonly performed ... etiology, research presented today at the American Orthopaedic Society ... that pain relief from this diagnostic injection may not ... “Our study looked to assess if the amount of ...
(Date:3/28/2015)... Vegas, NV (PRWEB) March 28, 2015 ... for patients with Type V AC joint injuries, according ... study, presented today at the American Orthopaedic Society for ... personnel returned to duty faster when surgery was not ... patients, with 7 receiving surgical treatment and 17 receiving ...
(Date:3/28/2015)... 28, 2015 Andrew Hawley of Vintage Rock ... psychedelic concert posters. The Who and the Doors played together ... 2, 1968. According to Hawley, “The Who toured the United ... and college campuses. Perhaps the most famous Who poster was ... and the Doors on August 2, 1968 at the Singer ...
(Date:3/28/2015)... (PRWEB) March 28, 2015 Aureus ... healthcare staffing, including physical therapy jobs, has announced ... the Ohio Physical Therapy Association Annual Conference to ... Columbus Downtown Hotel in Columbus, OH. , ... opportunities, and exhibits with products and services. ...
(Date:3/28/2015)... Vegas, NV (PRWEB) March 28, 2015 ... groundbreaking new method of sustainable health. After 18 years ... of life, including professional UFC contenders, Dr. Jon Petrick ... this summer. , Just some of the immediate benefits ... energy and vitality, increased levels of strength of the ...
Breaking Medicine News(10 mins):Health News:Pain Injections for Hip Arthroscopy Patients May Not Predict Surgical Outcomes 2Health News:For Type V AC Joint Injuries, Early Surgery May Not Be the Best Approach 2Health News:Avid Collector from Vintage Rock Posters, Inc. Announces His Search For&nbsp;Original 1960's Who Psychedelic Concert Posters. 2Health News:Healthcare Staffing Leader, Aureus Medical Group, to Exhibit at the Ohio Physical Therapy Association Annual Conference 2Health News:Celebrity Chiropractor Jon Petrick to Release Sustainable Health System this Summer 2
... worst fears, a national study has shown that being ... or hip fracture, can lead to long-term institutionalization in ... discharge to a skilled nursing facility -- a common ... at "extremely high risk" of needing long-term nursing home ...
... Ohio -- The bacterium that causes tuberculosis has a unique ... part of the body,s defense. New research suggests this represents ... hidden from the human immune system. Researchers found that ... called lipomannan that can stop production of an important protein ...
... , MONDAY, Oct. 3 (HealthDay News) -- ... from early, intensive therapy to improve their social and ... University of Missouri. "It,s important for children with ... Mazurek, assistant professor in the School of Health Professions ...
... (HealthDay News) -- In Utah, people suspected of child abuse ... of adult homicide, and they receive similar sentences, according to ... who have failed to care for or harmed their children, ... top five causes of childhood death in the United States," ...
... -- There,s more than one way to mop up after ... Medicine at the University of Pennsylvania report in Nature ... cells orchestrate the body,s repair response following flu infection. , ... pandemic, an estimated 200,000 people are hospitalized because of the ...
... cell lung cancer (NSCLC) the accurate determination of the ... an individualized treatment plan. Research from the October issue ... a new way for this information to be collected ... bronchoscopy that has high diagnostic accuracy for the detection ...
Cached Medicine News:Health News:Medicare patients at risk of long-term institutionalization after hospital stay 2Health News:Medicare patients at risk of long-term institutionalization after hospital stay 3Health News:Tuberculosis bacterium's outer cell wall disarms the body's defense to remain infectious 2Health News:Tuberculosis bacterium's outer cell wall disarms the body's defense to remain infectious 3Health News:Early, Intensive Therapy Better for Kids With Autism, Study Finds 2Health News:Conviction Rates Similar for Suspects of Child, Adult Murder in Utah 2Health News:Rebooting the system: Immune cells repair damaged lung tissues after flu infection 2Health News:Virtual fly-through bronchoscopy yields real results 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 ...
... 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 ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... 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: