WASHINGTON (AP) — Scientists toward the Food and drug Administration declare that an Amgen drug slowed the divulge of cancer to the bone in men by hard-to-treat prostate cancer, notwithstanding that the drug did not extend life and carried signifying side effects.

The Food and physic Administration will ask a panel of externality experts on Wednesday whether the benefits of Amgen's Xgeva overpoise its risks, which included bone disorder in about 5 percent of patients apprehension the drug. The agency posted its retrospect of the drug online Monday spring-time ahead of the meeting.

Xgeva is already approved for preventing fractures in cancerous bones, and towards osteoporosis, in a different formulation called Prolia.

Now Amgen has asked the FDA to appreciate the injectable drug as a prophylactic measure for men with recurring prostate cancer that is at aloft risk of spreading to the bone. Men must have also attempted and failed handling with hormone therapy.

A 1,432-quiet study conducted by Amgen showed the put ~s into slowed the spread of cancer to the bone ~ means of about 4.2 months when compared to patients who believed placebo. While that delay was statistically momentous, the FDA's reviewers questioned whether it is "every adequate measure of clinical benefit" during the term of patients with prostate cancer.

FDA's review notes that the drug did not grow overall survival, with patients in the medicine and placebo groups living about the same amount of time.

Additionally, five percent of patients seizure Xgeva experienced the side effect of osteonecrosis of the ~-bone, in which the bone dies on this account that of poor blood supply.

While the FDA rod does not openly recommend against the unused use for the drug, they swindle quote from an editorial in the Lancet that said the company's findings adhering Xgeva "'do not support its ample use as a preventive agent in spite of bone metastases in prostate cancer.'"

ISI algebraist Mark Schoenebaum said the FDA's negative revise was consistent with analyst expectations.

"As was in most cases expected by us and much of the Street, the FDA is censorious of the data, questioning the clinical meaningfulness of the earliest endpoint," Schoenebaum wrote in an email.

Even suppose that the FDA ultimately approves the hint, Schoenebaum estimates modest U.S. sales of concerning $300 million. The FDA is expected to do its final decision by late April.

Shares of Thousand Oaks, Calif.-based Amgen lay prostrate $1.80, or 2.6 percent, to $67.48 by share in morning trading.

Doctors appliance a variety of treatments and interventions to pleasure prostate cancer, depending on the send away in haste of the cancer's growth and the persistent's age, among other factors. Patients through fast-growing prostate tumors often greet hormone therapy to stop production of testosterone, what one. fuels cancer growth.

All of the men in Amgen's study had tumors that did not reply well to hormone therapy, but had not yet spread beyond the prostate. While there are multiple drugs for both seasonably and late-stage prostate cancer, Amgen argues "there is a gap in the manipulation plan for those patients" enrolled in its study.

Xgeva and Prolia, the osteoporosis formulation, had combined sales of $554 the great body of the people in 2011, their first full year attached the market.

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