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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
07/22/201616:30:00Amgen Announces Webcast Of 2016 Second Quarter Financial Results
07/22/201616:00:00Amgen Announces 2016 Third Quarter Dividend
07/22/201601:00:00Amgen And UCB Submit Biologics License Application For Romosozumab...
07/21/201612:50:00Amgen and Allergan Study Finds Biosimilar Comparable to Herceptin
07/21/201612:37:00Amgen and Allergan Study Finds Biosimilar Comparable to Herceptin
07/21/201609:00:00Amgen And Allergan Announce Top-Line Results From Phase 3 Study...
07/20/201620:29:00Amgen Announces Settlement Of Securities Litigation
07/20/201607:40:00Technical Coverage on Biotechnology Equities -- Galena Biopharma...
07/13/201621:00:00Amgen And Daiichi Sankyo Announce Agreement To Commercialize...
07/12/201619:20:00Amgen Biosimilar Gets Thumbs-Up From FDA Panel
07/12/201607:30:00Amgen To Discuss Data Supporting Biologics License Application...
07/11/201609:00:00FDA Approves First And Only Single Monthly Injection For A PCSK9...
07/06/201617:50:00Western Digital Names New CFO, Boosts Guidance
07/04/201601:00:00European Commission Approves Extended Indication For Amgen's...
06/22/201618:00:00Amgen Sponsors QB3@953 Incubator For Life Science Startups
06/20/201608:25:00Biotechnology Stocks Under Review - Eleven Biotherapeutics, Relypsa...
06/17/201616:00:00Amgen Appoints Esteban Santos Executive Vice President, Operations
06/15/201616:58:28Annual Report of Employee Stock Plans (11-k)
06/15/201616:51:42Annual Report of Employee Stock Plans (11-k)
06/14/201616:55:30Current Report Filing (8-k)

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