Navigation Links
Amgen Submits Application to Expand Indication for XGEVA® (Denosumab) to Prevent or Delay Spread of Prostate Cancer to the Bone
Date:6/27/2011

THOUSAND OAKS, Calif., June 27, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or delay the spread of cancer to the bone.

The sBLA submission is based on a pivotal Phase 3 Study ('147) evaluating XGEVA versus placebo in 1,432 men with castrate-resistant prostate cancer. Results of the '147 study demonstrate that XGEVA significantly prolonged bone metastasis-free survival by more than four months compared with placebo (29.5 versus 25.2 months, respectively) in men with castrate-resistant prostate cancer that had not yet spread to the bone.  Bone metastasis-free survival is a composite measure of the development of bone metastases or death.

"The successful outcome of this study provides clinical evidence supporting the view that tumors activate the RANK Ligand pathway to penetrate bone," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.  "XGEVA has the potential to become a significant advance for patients with castrate-resistant prostate cancer who currently have no treatment options to help prevent the spread of cancer to their bones."

Bone is one of the most common places for cancer to spread. In fact, up to 90 percent of men with advanced prostate cancer will have their tumor spread to the bone.(i),(ii),(iii) With effective therapies now in place for both early (castrate-sensitive) prostate cancer and advanced (castrate-resistant) metastatic prostate cancer, there is a gap in the treatment plan for those patients who are castrate-resistant but have n
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related biology technology :

1. Amgen Announces Webcast of 2008 Third Quarter Financial Results
2. Amgens Third Quarter 2008 Adjusted Earnings Per Share Increased 14 Percent to $1.23
3. Call for Applications: The Amgen Award for Science Teaching Excellence
4. Amgen to Webcast 2008 Business Review Meeting on November 7 From Millennium Hotel in New York
5. Amgen Positioned to Deliver Attractive Growth Over Next Five Years
6. Amgen Foundation Announces $2.5 Million Expansion of Amgen Scholars Program to Europe
7. Amgen to Present at the 27th Annual JP Morgan Healthcare Conference
8. Amgen Announces Webcast of 2008 Fourth Quarter and Full Year Financial Results
9. Amgens Breakaway from Cancer Initiative Expands to Help Cancer Patients Access Broad Spectrum of Cancer Resources and Services
10. Amgens Fourth Quarter 2008 Adjusted Earnings Per Share Increased 6 Percent to $1.06; Full Year 2008 Adjusted Earnings Per Share Increased 6 Percent to $4.55
11. FDA Accepts Amgens Submission and Files Biologics License Application for Denosumab
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2014)... , September 18, 2014 /PRNewswire/ ... Markets ( http://www.researchandmarkets.com/research/czvg3s/biocompatible ) has announced ... Materials - Global Strategic Business Report" ... (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ,This report analyzes the ... US$ Million by the following Product ...
(Date:9/18/2014)... -- Research and Markets has announced the ... Industry Report, 2014-2017" report to their offering. ... can differentiate into specialized cells and can divide (through ... can be applied to treatment of cardiovascular diseases, leukemia ... damage or lesion of liver, kidney and other parenchymal ...
(Date:9/18/2014)... , Sept. 18, 2014 Research ... "Global Companion Diagnostics (Polymerase Chain Reaction, In-situ hybridization, ... report to their offering. The global ... CAGR of 22.7% from 2014 to 2019. Factors such ... growing adoption of companion diagnostics by the pharmaceutical industry, ...
(Date:9/18/2014)... , Sept. 18, 2014  MEI Pharma, Inc. (Nasdaq: ... clinical development of novel therapies for cancer, announced today that ... Officer, will present at BioCentury,s NewsMakers in the Biotech ... a.m. Eastern time from the Millennium Broadway Hotel & Conference ... webcast of the presentation can be accessed at www.meipharma.com ...
Breaking Biology Technology:Biocompatible Materials - Global Strategic Business Report 2014 2Biocompatible Materials - Global Strategic Business Report 2014 3Global and Chinese Stem Cell Industry Report, 2014-2017 2Global and Chinese Stem Cell Industry Report, 2014-2017 3Global Companion Diagnostics (Polymerase Chain Reaction, In-situ hybridization, Immunohistochemistry) Market - Trends & Forecasts to 2019 2Global Companion Diagnostics (Polymerase Chain Reaction, In-situ hybridization, Immunohistochemistry) Market - Trends & Forecasts to 2019 3MEI Pharma To Present At BioCentury's NewsMakers Conference 2MEI Pharma To Present At BioCentury's NewsMakers Conference 3
... consulting firm ,based in Draper, UT, named Epic Systems ... Report Card. The study, which included 200 vendors, was ... and clinicians representing over 4,000 healthcare facilities. , ,KLAS ... information technology (HIT) vendors and releases its Top 20 ...
... game makers , ,Eau Claire, WI-- Silicon ... Graphics of Wilsonville, Ore., to offer improved custom ... spectrum. , ,The business collaboration is meant to speed ... additional manufacturing operations due to undetected errors in very ...
... intranet infrastructure helped Cisco Systems - the ... explosive growth in the late '80s ad early '90s. ... has come from careful expansion of the company's product ... Marquette University Business Leaders Forum Breakfast. , ...
Cached Biology Technology:Silicon Logic Teams Up to Save Money 2Cisco Chairman Praises University Research 2Cisco Chairman Praises University Research 3
(Date:9/18/2014)... be cheerful, happy-go-lucky characters, so you might expect that ... , In fact some dogs are distinctly more pessimistic ... , "This research is exciting because it measures ... non-invasively. It offers researchers and dog owners an insight ... said Dr Melissa Starling, from the Faculty of Veterinary ...
(Date:9/18/2014)... it that when people are too stressed they are ... the Brain Mind Institute (BMI) at EPFL have just ... between chronic stress and the loss of social skills ... attacks a synaptic regulatory molecule in the brain. This ... Communications . , Carmen Sandi,s team went to ...
(Date:9/17/2014)... health care to reproductive technologies, the justice and ... of people to identify key issues, articulate their ... find the most defensible ways forward. But what ... societal conversations?, The Hastings Center and the Presidential ... teamed up to publish a series of essays ...
Breaking Biology News(10 mins):Dogs can be pessimists too 2Dogs can be pessimists too 3How stress tears us apart 2Why bioethics literacy matters 2Why bioethics literacy matters 3
... Now, researchers at Yonsei University in Seoul, Republic of ... a layer of silver ions that can prevent growth ... Salmonella typhimurium and Campylobacter jejuni . The ... be particularly useful for applications in disaster recovery and ...
... is killing fishers in the southern Sierra Nevada, according ... scientists from the U.S. Forest Service,s Pacific Southwest Research ... Berkeley, and the Integral Ecology Research Center. ... team documented that rodenticides were being found in the ...
... 27, 2013 /PRNewswire-iReach/ -- Industry leader in healthcare ... to improve the family waiting room experience.  While ... the company now offers a customizable multilingual whiteboard ... preference.  Over 3o languages are currently available, with ...
Cached Biology News:Spinning up antibacterial silver on glass 2Illegal marijuana grows threaten fishers in the southern Sierra Nevada 2PatientStream announces the industry's first Multilingual family waiting room board 2PatientStream announces the industry's first Multilingual family waiting room board 3
Mouse HAI-1 Ectodomain MAb (Clone 199732)...
... Recognizes K+ Cl- Cotransporter-1 ... no significant sequence homology ... CCC.,SPECIES REACTIVITIES: The immunogen ... in human, mouse, porcine ...
IEX-1 S/L (H-20)...
Mouse monoclonal [1.T.4] to WAVE 1 ( Abpromise for all tested applications). Antigen: His6 fusion protein corresponding to full-length rat WAVE1. Entrez Gene ID: 8936...
Biology Products: