Member access

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


News SummaryMost relevantAll newsSector 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;

React to this article
Latest news on AMGEN, INC.
12:35a AMGEN : Compugen Adds to Business Development Team
02/27 AMGEN : Receives Positive CHMP Opinion For Use Of Vectibix® (panitumumab) As Fir..
02/26 AMGEN : Compugen Bolsters Business Development Team
02/25 AMGEN : Announces Positive Results From Head-To-Head Study Comparing The Efficac..
02/25 AMGEN : To Present At The Cowen And Company 35th Annual Health Care Conference
02/25 XENCOR : Recaps 4Q and Full Year 2014 Financial Results
02/24 XENCOR : Posts 4Q and Full Year 2014 Financial Results
02/23 AMGEN : Health and Human Services Department (HHS); Food and Drug Administration..
02/23DJMerck to Team With NGM to Develop Diabetes and Obesity Treatments -- Update
02/20 XENCOR : Reports Fourth Quarter and Full Year 2014 Financial Results
Duration : Period :
Amgen, Inc. Technical Analysis Chart | AMGN | US0311621009 | 4-Traders
Income Statement Evolution
More Financials
Dynamic quotes