Amgen fails to get FDA advisory backing for extended use of Xgeva

The world’s largest independent biotech firm, Amgen (Nasdaq: AMGN), has failed to convince a Food and Drug Administration advisory panel that its Xgeva (denosumab), already approved for marketing in the USA to prevent bone pain and fractures caused by bone metastases in prostate cancer patients (The Pharma Letter November 19, 2010), should be approved to delay tumors spreading to bones in this patient population. Amgen stock declined 1.6% to $68.06 by close of trading yesterday.

Members of the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to one that the benefits of the drug did not outweigh its risks, which included bone disease in about 6% of 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 panelist Ronald Richardson of the Mayo Clinic quoted by The Associated Press. The lone patient representative on the panel voted in favor.

Chairman of the ODAC Wyndham Wilson, a research chief at the National Cancer Institute, 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 Dr Wilson, quoted by the New York Times.