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Amgen: FDA Aims For April Decision On Xgeva For Prostate Cancer

Amgen Inc. (AMGN) said the U.S. Food and Drug Administration is aiming for next April to decide whether to approve its bone cancer drug to help reduce the risk of a type of prostate cancer from spreading to the bone.


Amgen, which faces numerous pressures from rising competition and regulatory issues related to its aging portfolio of drugs, has been looking at Xgeva's various uses to invigorate its profit growth.


The company in December reported Xgeva helped delay the spread of prostate cancer to bone by 4.2 months in key late-stage data that may open up a new use for the potential blockbuster drug.


The treatment has been approved in the U.S., Canada and the European Union to prevent complications in patients where cancer from solid tumors has spread to the bone, but isn't approved for multiple myeloma patients.


Amgen last month reported a 2.7% decline in second-quarter earnings on higher development and marketing costs. Revenue rose 4% as sales of the company's bone drugs gained steam, while its anemia products continued to weaken.


Shares were up 1.5% at $52.73 in early trading amid a broad market upturn. The stock is down 3.8% this year, less than the broader market.

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