Member access

4-Traders Homepage  >  Shares  >  Nasdaq  >  Amgen, Inc.    AMGN   US0311621009

AMGEN, INC. (AMGN)

131
SummaryQuotesChart AnalysisNewsCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll news 

Amgen, Inc. : Amgen : FDA Letter Rejects Expanded Use Of Xgeva For Prostate Cancer

04/27/2012 | 07:22am US/Eastern

Amgen Inc. (AMGN) received a complete response letter from the U.S. Food and Drug Administration rejecting the expanded use of Xgeva in men with prostate cancer that hasn't spread to the bones.

According to the drug maker, the FDA letter said the agency can't approve the supplemental biologics license application in its present form because the effect on bone metastases-free survival doesn't outweigh the risks, such as osteonecrosis of the jaw, a rare jaw-decay problem.

"We are reviewing the complete response letter and will work with FDA to determine any next steps," said Sean E. Harper, executive vice president of research and development.

Xgeva is currently approved to delay fractures and other bone injuries in patients whose cancer has already spread to the bones. It is also sold under the brand name Prolia as an osteoporosis treatment, but is administered at a lower dose. Xgeva's and Prolia's combined sales in 2011 topped $550 million.

A federal advisory panel in February rejected Amgen's proposal to expand the bone drug's use, saying it was unclear whether the results were clinically meaningful.

Amgen's study of Xgeva in men with prostate cancer that hadn't responded to previous therapies, but hadn't yet spread to the bones showed the drug prolonged median bone metastatis-free survival by 4.2 months.

Shares closed Thursday at $70.79 and were inactive premarket. The stock it up 10% so far this year.

-By Melodie Warner, Dow Jones Newswires; 212-416-2283; melodie.warner@dowjones.com

Latest news on AMGEN, INC.
4d ago AMGEN : Change in Directors or Principal Officers, Financial Statements and Exhi..
4d ago AMGEN : Announces Appointment Of R. Sanders Williams To Board Of Directors
4d ago AMGEN : Announces 2014 Fourth Quarter Dividend
4d agoDJAmgen Files Patent Infringement Suit Over Cholesterol Drug
4d ago AMGEN : Files Lawsuit Against Sanofi And Regeneron For Patent Infringement
10/14 AMGEN : BiTE Immunotherapy Blinatumomab Gets FDA Priority Review Designation
10/10 COGNIZANT TECHNOLOGY SOLUTIONS : Nasdaq 100 Movers: NXPI, CTSH
10/09 AMGEN : BiTE® Immunotherapy Blinatumomab Receives FDA Priority Review Designatio..
10/08 AMGEN : Announces Positive Top-Line Results From Phase 3 Study Evaluating The Ef..
10/01 AMGEN : The Lancet Publishes Two Phase 3 Studies Showing Cholesterol-Lowering Me..
Advertisement
Chart
Duration : Period :
Amgen, Inc. Technical Analysis Chart | AMGN | US0311621009 | 4-Traders
Income Statement Evolution
More Financials
Dynamic quotes  
ON
| OFF