Navigation Links
Amgen Announces PDUFA Date for XGEVA® Supplemental Biologics License Application
Date:8/22/2011

THOUSAND OAKS, Calif., Aug. 22, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) will target a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2012 for the supplemental Biologics License Application (sBLA) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. Bone is one of the most common places for cancer to spread. If approved in this expanded indication, XGEVA would become the first therapy licensed to prevent or delay the spread of cancer to bone.

About XGEVA

XGEVA is the first and only RANK Ligand inhibitor approved by the FDA indicated for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. XGEVA was initially approved following a six month priority review by the FDA.  XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma. XGEVA is the first novel bone metastases treatment for advanced cancer patients in nearly a decade. Delivered as an every four week 120 mg subcutaneous injection, XGEVA provides a unique option for urologists and oncologists to prevent SREs in patients with advanced cancer.

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
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

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:9/30/2014)... Summary This report presents the ... regarding their Information & Communications Technology (ICT) investment ... allocate their ICT budgets across the core areas ... communications, and consulting. Key Findings ... that X% of respondents anticipate an increase in ...
(Date:9/30/2014)... Investor-Edge has initiated coverage on ... ), Aeterna Zentaris Inc. (NASDAQ: AEZS ), ... Biopharmaceuticals Inc. (NYSE MKT: NAVB), and Exact Sciences Corporation ... be accessed at: http://investor-edge.com/register . On ... 4,505.85, down 0.14%, the Dow Jones Industrial Average finished ...
(Date:9/30/2014)... , Sept. 30, 2014  Come fall, many children, ... or "what" they want to be for Halloween. And, ... look with decorative contact lenses bought without a prescription. ... year that people purchase and wear contact lenses without ... American Eye-Q ® consumer survey, 17 percent of ...
Breaking Medicine Technology:ICT investment trends in pharmaceuticals - Enterprise ICT spending patterns through to the end of 2015 2ICT investment trends in pharmaceuticals - Enterprise ICT spending patterns through to the end of 2015 3Watch List for Biotech Equities - Immunomedics, Aeterna Zentaris, OPKO Health, Navidea Biopharma, and Exact Sciences 2Watch List for Biotech Equities - Immunomedics, Aeterna Zentaris, OPKO Health, Navidea Biopharma, and Exact Sciences 3Watch List for Biotech Equities - Immunomedics, Aeterna Zentaris, OPKO Health, Navidea Biopharma, and Exact Sciences 4Watch List for Biotech Equities - Immunomedics, Aeterna Zentaris, OPKO Health, Navidea Biopharma, and Exact Sciences 5The Spooky Truth: What You Need To Know About Contact Lens Hygiene 2The Spooky Truth: What You Need To Know About Contact Lens Hygiene 3
(Date:9/30/2014)... OH (PRWEB) September 30, 2014 ... blades sporting the iconic pink ribbon in support of ... a popular month for businesses and non-profits to “go ... worthwhile cause. , AutoTex PINK is a woman-owned company ... wipers. They are committed to partnering with their ...
(Date:9/30/2014)... 30, 2014 Teeth replacement and restoration ... Institute in Oxnard and Thousand Oaks, Calif., is in ... to provide training on full mouth rehabilitation. , “Full ... implants, providing cosmetic dentistry, correcting bite issues, and resolving ... Dr. Jivraj, who has traveled to India to speak ...
(Date:9/30/2014)... 30, 2014 Loffler Companies, an ... technology and services was recognized by BEI as ... (FCE) in 2013. This prestigious rating means that ... time and for an extended period following, optimizing ... 20 years BEI Services has been the trusted ...
(Date:9/30/2014)... In honor of National Breast Cancer Awareness Month ... battles, Incredible Veins, Body & Skin is offering survivors ... , “For cancer patients who receive radiation treatment, ... their skin to accurately aim the radiation on the ... they decide to have their tattoo removed as the ...
(Date:9/30/2014)... 2014 Julie Kuriakose, MD; ... , will discuss how restaurants can become more allergy-friendly ... dietary restrictions at the 2014 Allergy Eats Food ... October 21 in New York City. , “I’m extremely ... to such an engaged industry audience. As food allergies ...
Breaking Medicine News(10 mins):Health News:Change Your Blades … Change A Life! AutoTex PINK Wiper Blades Are Helping Wipe Out Breast Cancer 2Health News:Change Your Blades … Change A Life! AutoTex PINK Wiper Blades Are Helping Wipe Out Breast Cancer 3Health News:World-Renowned Dental Implant Expert, International Instructor in India Speaking about Reconstructive Dentistry 2Health News:World-Renowned Dental Implant Expert, International Instructor in India Speaking about Reconstructive Dentistry 3Health News:World-Renowned Dental Implant Expert, International Instructor in India Speaking about Reconstructive Dentistry 4Health News:World-Renowned Dental Implant Expert, International Instructor in India Speaking about Reconstructive Dentistry 5Health News:Loffler Companies Rated Number One Among U.S. Dealers in Service “First Call Effectiveness” 2Health News:Loffler Companies Rated Number One Among U.S. Dealers in Service “First Call Effectiveness” 3Health News:Incredible Veins, Body & Skin Takes A Stand Against Breast Cancer With PicoSure® By Cynosure 2Health News:Hudson Allergy’s Dr. Julie Kuriakose to Speak at Prestigious Food Allergy Conference in New York City 2Health News:Hudson Allergy’s Dr. Julie Kuriakose to Speak at Prestigious Food Allergy Conference in New York City 3
... This strategy beat out either therapy alone, researchers found ... combination of cognitive behavior therapy plus antidepressant drugs is ... thoughts and behavior in depressed teens, new research shows. ... October issue of the journal Archives of General ...
... Health Inc. (Amex: OPK ),has announced the appointment ... Dr. Goldschmidt is the Senior Vice President for Medical,Affairs ... Miller School of,Medicine. Dr. Goldschmidt formerly served as Chairman ... "We are delighted to welcome an exceptional healthcare ...
... Cottage Hospital,which has served thousands of patients from ... 85 years, has rejoined the Henry Ford,Health System. ... Health,System. In 1998, Cottage became part of the Bon ... part of the joint venture,Henry Ford Health System owned ...
... Summit speakers Kenneth,Thorpe, Ph.D. of Partnership to Fight ... on Health, WASHINGTON, Oct. 1 Overhauling ... candidates, but one top,expert believes any serious proposal ... PhD., helped launch the Partnership to,Fight Chronic Disease ...
... 1 Crdentia Corp. (OTC Bulletin,Board: CRDT), a ... posted an exclusive interview on their website with,Michael ... In the interview, Mr. Yao describes how Crdentia,s ... facility contracts and 1,000 travel nurse,needs nationwide. He ...
... that typically fight bacteria, study finds , MONDAY, Oct. ... urban air pollution, shuts down early immune responses in ... vulnerable to bacteria and other foreign invaders, research shows. ... with increased cardiovascular and pulmonary hospitalizations and deaths, but ...
Cached Medicine News:Health News:Drug Plus Psychotherapy Best Treatment for Depressed Teens 2Health News:OPKO Health Appoints Pascal J. Goldschmidt to Board of Directors 2Health News:OPKO Health Appoints Pascal J. Goldschmidt to Board of Directors 3Health News:Grosse Pointe's Cottage Hospital Joins Henry Ford Health System 2Health News:Grosse Pointe's Cottage Hospital Joins Henry Ford Health System 3Health News:URAC Releases Issue Briefs Examining Stakeholders Views of Care Coordination Along the Healthcare Continuum 2Health News:URAC Releases Issue Briefs Examining Stakeholders Views of Care Coordination Along the Healthcare Continuum 3Health News:Crdentia's National Director of Travel Services Provides an Exclusive Interview on the Growth of Crdentia's Travel Nurse Division 2
... 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 ...
... 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 ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... 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 ...
Medicine Products: