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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
02/07/201618:15:00Drug Industry Launches Ad Campaign Aimed at Lawmakers
02/05/201617:06:00Amgen To Present At The Leerink Partners 5th Annual Global Healthcare...
02/04/201616:17:00Phase 3 Study of BLINCYTO® (Blinatumomab) Met Primary Endpoint...
02/04/201616:00:00Amgen Announces Positive Top-Line Results From Phase 3 GAUSS-3...
01/28/201616:40:00Amgen Profit Rises 39%; 2016 Outlook Raised
01/28/201616:31:00Amgen Profit Rises 39%; 2016 Outlook Raised
01/28/201616:00:00Amgen's 2015 Revenues Increased 8 Percent To $21.7 Billion And...
01/25/201617:20:00FDA Accepts Amgen's Biosimilar Biologics License Application...
01/25/201616:03:00Amgen Announces Webcast of 2015 Fourth Quarter and Full Year...
01/23/201613:00:00Vectibix® (panitumumab) And Best Supportive Care Improves Overall...
01/22/201601:00:00Amgen's Repatha® (Evolocumab) Approved As First PCSK9 Inhibitor...
01/21/201616:32:00FDA Approves New Kyprolis® (Carfilzomib) Combination Therapy...
01/11/201612:50:00Celgene Names New CEO, Cuts 2015 Profit Outlook
01/10/201620:33:00Drugmakers Keep Raising Prices Despite Criticisms
01/07/201616:05:00Amgen To Present At The 34th Annual J.P. Morgan Healthcare Conference
12/18/201501:00:00European Commission Approves Amgen's IMLYGIC™ (talimogene laherparepvec) A...
12/15/201516:45:00Amgen Raises Quarterly Dividend 27%
12/15/201516:00:00Amgen Announces 27 Percent Increase In 2016 First Quarter Dividend
12/14/201519:10:00Amgen Takes Back Rights to Prolia, Xgeva and Vectibix Drugs
12/14/201517:50:00Amgen Takes Back Rights to Prolia, Xgeva and Vectibix Drugs

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