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FDA panel votes against Amgen's Xgeva for prostate cancer

February 08, 2012

Washington — A panel of cancer experts voted against a new use for Amgen Inc.'s Xgeva in prostate cancer on Wednesday, saying the drug's ability to slow the spread of the disease did not translate into meaningful benefits for patients.

The Food and Drug Administration's cancer drug panel voted 12 to 1 that the benefits of the drug did not outweigh its risks, which included bone disease in about 6% of patients. The FDA is not required to follow the group's advice, although it often does.

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

Amgen has asked the FDA to approve the injectable drug as a preventive measure for men with recurring prostate cancer that is at high risk of spreading to the bone. At the public meeting Wednesday, Amgen scientists pointed to results of a company study showing patients taking Xgeva experienced a four-month delay in the spread of cancer to the bones around the prostate.

Panelists termed this a "statistical benefit" but not one that resulted in increased survival or higher quality of life for patients.

"The effect of the studied compound is quite weak with no effect on survival or the overall course of the disease in general," said Dr. Ronald Richardson of the Mayo Clinic.

All of the panel's physicians voted against the Thousand Oaks company's application. The lone patient representative on the panel voted in favor.

Many cancer drugs approved by the FDA do not extend survival but instead slow the growth of tumors or their spread to other parts of the body. In recent years, cancer experts have debated the meaningfulness of these measures. Panel chairman Dr. Wyndham Wilson acknowledged that delaying the disease's spread to the bone could be meaningful but suggested the drug would have to do so for more than four months.

"If it was one year we probably wouldn't even be here today. No one is denying that, but the magnitude here is quite low" said Wilson, a research chief at the National Cancer Institute.

Panelists also raised concerns about exposing patients to the drug's side effects, including osteonecrosis of the jaw, in which the bone dies because of poor blood supply.

Doctors use a variety of treatments and interventions to treat prostate cancer, depending on the speed of the cancer's growth and the patient's age, among other factors. Patients with fast-growing prostate tumors often receive hormone therapy to stop production of testosterone, which fuels cancer growth.

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

Amgen said in a statement after the meeting that it would continue discussions with the FDA as it reviews the company's application. A final decision is expected by April 26.

Xgeva and Prolia, the osteoporosis formulation, had combined sales of $554 million in 2011, their first full year on the market.

Shares of Amgen fell $1.11, or 1.6%, to $68.06.

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