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

DOW JONES NEWSWIRES 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

Stock News for Amgen Inc. (AMGN)
DateTimeHeadline
07/31/201510:00:12U.S. Hot Stocks: Hot Stocks to Watch
07/31/201509:44:26U.S. Hot Stocks: Hot Stocks to Watch
07/30/201519:05:00Initial Statement of Beneficial Ownership (3)
07/30/201518:07:11Amgen Raises 2015 Outlook, Results Beat Expectations -- 2nd Update
07/30/201516:50:18Amgen Raises 2015 Outlook, Results Beat Expectations
07/30/201516:43:25Amgen Raises 2015 Outlook, Results Beat Expectations -- Update
07/30/201516:33:30Amgen Raises 2015 Outlook, Results Beat Expectations
07/30/201516:21:01Current Report Filing (8-k)
07/30/201516:05:00Amgen Announces Appointment Of Fred Hassan To Board Of Directors
07/30/201516:01:00Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4...
07/28/201517:46:00Amgen Announces 2015 Third Quarter Dividend
07/28/201512:26:16Merck Earnings Hurt by Arthritis Drug Knockoffs
07/27/201516:01:00Amgen Announces Webcast of 2015 Second Quarter Financial Results
07/24/201515:21:49Correction to Amgen/Kyprolis Article
07/24/201515:00:06FDA Approves Cholesterol Drug From Regeneron, Sanofi
07/24/201513:30:24FDA Approves Amgen's Kyprolis for Earlier Myeloma Treatment
07/24/201513:25:56FDA Approves Amgen's Kyprolis As a Second-Line Multiple Myeloma...
07/24/201512:40:00FDA Approves Kyprolis® (carfilzomib) For Combination Use In...
07/24/201509:10:04AbbVie's Revenue Growth Misses Expectations
07/24/201508:57:08AbbVie's Revenue Growth Misses Expectations

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