Navigation Links
FDA to Review Potential New Use of XGEVA® (Denosumab) at Oncologic Drugs Advisory Committee Meeting
Date:12/29/2011

ogists and oncologists to prevent SREs in patients with bone metastases from solid tumors.

XGEVA is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts (the cells that break down bone). XGEVA prevents RANK Ligand from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction.

XGEVA has been studied in over 7,000 patients with cancer. In clinical trials, XGEVA demonstrated a clinically meaningful improvement compared to the previous standard of care in preventing bone complications. XGEVA is also being investigated for the potential use to delay the onset of bone metastasis in adjuvant breast cancer.

XGEVA Important Safety Information

XGEVA can cause severe hypocalcemia. Correct pre-existing hypocalcemia prior to XGEVA treatment. Monitor calcium levels and administer calcium, magnesium and vitamin D as necessary. Advise patients to contact a healthcare professional for symptoms of hypocalcemia.

Osteonecrosis of the jaw (ONJ) can occur in patients receiving XGEVA. Patients who are suspected of having or who develop ONJ while on XGEVA should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

The most common adverse reactions in patients receiving XGEVA were fatigue/asthenia, hypophosphatemia and nausea. The most common serious adverse reaction in patients receiving XGEVA was dyspnea. The most common adverse reactions resulting in discontinuation of XGEVA were osteonecrosis and hypocalcemia. Please visit www.amgen.com or www.xgeva.com for full U.S. prescribing information.

XGEVA Regulatory Status

XGEVA has been approved in the U.S., Canada, the European Union (EU), Switzerland, Australia and Russia for the prevention of SREs i
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of Obesity
2. Bipartisan Group of 22 House Members ask CMS to Stop Prepayment Review Project that would Jeopardize Care for Medicare Beneficiaries
3. Anthera Announces Completion of Safety Review by DSMB for VISTA-16
4. Homecare Providers and Consumer Advocates Urge Congress to Stop Ineffective Medicare Payment Review Process for Mobility Equipment
5. M&A Surges, Companion Diagnostics Accelerate, and Early Detection Offers New Prospects, Finds PwCs Biennial Review of the In Vitro Diagnostics Industry
6. Physicians Capital Investments Announces Pedro Vergne-Marini, MD Named to Beckers ASC Review "350 People in the ASC Industry to Know"
7. Avreo Previews Version 7 RIS/PACS at RSNA
8. Futuremed and Cardinal Health Canada Inc. Report on Developments in Competition Bureau Review of the Proposed Acquisition
9. Regeneron Announces FDA Acceptance of ARCALYST® (rilonacept) Supplemental Biologics License Application for Review
10. U.S. Food and Drug Administration (FDA) Delays Review of Takedas Investigational Type 2 Diabetes Therapies, Alogliptin and Alogliptin/Pioglitazone
11. Columbia Laboratories and Watson Pharmaceuticals Confirm FDA Advisory Committee to Review Preterm Birth NDA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/21/2014)... , Nov. 21, 2014  Abaxis, Inc. (NasdaqGS: ... point-of-care instruments and consumables for the medical, research, and ... the veterinary and research markets in the ... a stock purchase agreement to acquire 100% of QCR ... based distribution organization. The transaction closed on ...
(Date:11/21/2014)... , 21. November 2014 /PRNewswire/ ... hat heute bekannt gegeben, dass die ... EMA) die Kennzeichnung als Orphan-Medizinprodukt an ... des Unternehmens zur Behandlung von Fibrodysplasia ... seltene, stark beeinträchtigende genetische Krankheit, die ...
(Date:11/21/2014)... N.Y. , Nov. 21, 2014  Cardinal Health, ... world,s largest health care services companies, and Henry Schein, ... provider of health care products and services to office-based ... the companies have entered into a long-term strategic agreement ... product offerings to office-based medical practices.  This strategic agreement ...
Breaking Medicine Technology:Abaxis Acquires UK-based Distribution Organization 2Abaxis Acquires UK-based Distribution Organization 3Abaxis Acquires UK-based Distribution Organization 4Clementia Pharmaceuticals erhält EMA-Kennzeichnung als Orphan-Medizin für Palovarotene zur Behandlung von Fibrodysplasia ossificans progressiva 2Clementia Pharmaceuticals erhält EMA-Kennzeichnung als Orphan-Medizin für Palovarotene zur Behandlung von Fibrodysplasia ossificans progressiva 3Cardinal Health And Henry Schein Enter Into Long-Term Strategic Agreement To Serve Physician Offices 2Cardinal Health And Henry Schein Enter Into Long-Term Strategic Agreement To Serve Physician Offices 3Cardinal Health And Henry Schein Enter Into Long-Term Strategic Agreement To Serve Physician Offices 4Cardinal Health And Henry Schein Enter Into Long-Term Strategic Agreement To Serve Physician Offices 5
... In the year since a devastating earthquake struck Haiti on ... world have launched and supported projects to help the country ... began, Rotary clubs started a $200,000 initiative to implement cholera ... waterborne disease. Rotary clubs worldwide have contributed more ...
... Cardinal Health plans to release second-quarter financial results for its ... of trading on the New York Stock Exchange. ... Feb. 3 at 8:30 a.m. EST to discuss second-quarter results. ... the Investor page at cardinalhealth.com/investors or dial 857-350-1669 passcode 24786608. ...
Cached Medicine Technology:Rotary Clubs Remain Committed to Rebuilding Quake-Ravaged Haiti 2Rotary Clubs Remain Committed to Rebuilding Quake-Ravaged Haiti 3Cardinal Health to Release Second-Quarter Results on Feb. 3 2
(Date:11/23/2014)... 2014 BambooFlooringChina.com , the world’s leader ... strand woven bamboo flooring collection. Now, the business is ... company’s CEO, the promotion is valid until Dec. 20, 2014. ... a smooth and dust-free surface, which makes it very easy ... industry, the company wants to make its website the best ...
(Date:11/22/2014)... Cancer researchers in New York and ... communication tunnels and the growth and spread of mesothelioma. ... on the Surviving Mesothelioma website. , Doctors at ... Minnesota have just released their study on tunneling nanotubes ... cells. They found that mesothelioma cells contain ...
(Date:11/22/2014)... Recently, Locks-Magnetic.com , one of ... promotion of mag locks for glass doors online. In ... on these fresh products. Customers can get more information ... doors are in excellent performance. Customers who want to ... soon as possible. They also can enjoy the ...
(Date:11/22/2014)... (PRWEB) November 22, 2014 “Due to my ... an inventor, from Gurnee, Ill. “While using the ice grip ... and I thought there needed to be a safer way ... the SPIKE BLOCK. , The SPIKE BLOCK offers added safety ... it would help to reduce injuries and damage associated with ...
(Date:11/22/2014)... PA (PRWEB) November 22, 2014 "My ... the pain caused by the machine," said an inventor ... she had to go back a second time because ... invention idea." , She developed the patent-pending MAMO EASY ... breast cancer. The design saves the patient from the ...
Breaking Medicine News(10 mins):Health News:Click Strand Woven Bamboo Flooring From Famous Bamboo Flooring Company BambooFlooringChina.com 2Health News:Study Links Cellular ‘Tunnels’ to Mesothelioma Proliferation, According to Surviving Mesothelioma 2Health News:Discounted Mag Locks for Glass Doors Revealed by Locks-Magnetic.com 2
... ... Club, the Endangered Habitats League and SOS Hills will honor "Avatar" ... Outstanding Social Responsibility in Media. "Avatar,s" themes closely mirror the ... residents are facing against Granite Construction, a powerful corporation that wants ...
... ... medical experience. , ... Scottsdale, AZ (PRWEB) March 3, 2010 -- NightHawk Radiology Services, the leading ... named two new physician leaders to its Medical Executive Team (MET), an influential group ...
... , ... ... ... ...
... ... ... ... ...
... forms of Leukaemia have identified a new drug target to ... diseased cells. The research, reported in EMBO Molecular Medicine ... if targeted could prevent diseased cells from developing. The ... Vienna, carried out their research on acute lymphoid leukaemia (ALL) ...
... from injuries to the distal biceps tendon may benefit from ... review article published in the March 2010 issue of the ... (JAAOS). Located in the front of the elbow, the distal ... muscle, and is responsible for two primary motions: , ...
Cached Medicine News:Health News:Temecula Environmental Groups & City to Honor "Avatar" Director James Cameron with First Ever Environmental Media Award 2Health News:Temecula Environmental Groups & City to Honor "Avatar" Director James Cameron with First Ever Environmental Media Award 3Health News:Temecula Environmental Groups & City to Honor "Avatar" Director James Cameron with First Ever Environmental Media Award 4Health News:NightHawk Radiology Services Expands Its Medical Executive Team 2Health News:NightHawk Radiology Services Expands Its Medical Executive Team 3Health News:VIDEO from Medialink and Juice Products Association: Teens Who Drink Juice Have Healthier Diets, Eat More Whole Fruit 2Health News:VIDEO from Medialink and Juice Products Association: Teens Who Drink Juice Have Healthier Diets, Eat More Whole Fruit 3Health News:VIDEO from Medialink and Juice Products Association: Teens Who Drink Juice Have Healthier Diets, Eat More Whole Fruit 4Health News:Diplomat Specialty Pharmacy Gets Aggressive in Seeking Funding Sources for Life Saving Drugs 2Health News:Diplomat Specialty Pharmacy Gets Aggressive in Seeking Funding Sources for Life Saving Drugs 3Health News:Diplomat Specialty Pharmacy Gets Aggressive in Seeking Funding Sources for Life Saving Drugs 4Health News:Diplomat Specialty Pharmacy Gets Aggressive in Seeking Funding Sources for Life Saving Drugs 5Health News:Diplomat Specialty Pharmacy Gets Aggressive in Seeking Funding Sources for Life Saving Drugs 6Health News:Targeting leukemia cell's gene 'addiction' presents new strategy for treatment 2Health News:Battling a biceps injury 2Health News:Battling a biceps injury 3
... Precision Hand Instruments were developed in surgeon's ... while still having an instrument with the ... the fear of the bending or breaking. ... manufactured to conform to the surgeon's hand. ...
... Arthrotek® Precision Hand Instruments were developed in ... feel, while still having an instrument with ... without the fear of the bending or ... and manufactured to conform to the surgeon's ...
... Arthrotek® Precision Hand Instruments were developed in ... feel, while still having an instrument with ... without the fear of the bending or ... and manufactured to conform to the surgeon's ...
This optimal design addresses low-cost, simple, non-invasive ankle distraction....
Medicine Products: