An advisory panel for the US Food and Drug Administration has rejected the use of Amgen’s drug Xgeva to prevent prostate cancer from spreading to the bones.
Xgeva is approved to delay bone injuries in patients whose cancer has already spread to the bones, but Amgen hopes to expand the drug’s use to treat men who are at a high risk of developing bone metastases.
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Amgen chief medical officer and senior vice president of global development Sean Harper said, "The development of bone metastasis is an irreversible, life-changing event for men living with castration-resistant prostate cancer and is associated with significant and progressive morbidity. Xgeva is the first agent to prolong bone metastasis-free survival and addresses this important unmet medical need."
Amgen’s phase three trial enrolled 1,432 men whose cancer had not responded to other therapies. In 80% of the study population Xgeva prolonged median bone metastasis-free survival time by six months compared with placebo, with a 16% reduction in risk. However, 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.
The Associated Press quoted Ronald Richardson of the Mayo Clinic as saying, "The effect of the studied compound is quite weak with no effect on survival or the overall course of the disease in general."
Panelists were also concerned about exposing patients to side affects such osteonecrosis of the jaw, which occurred in 5% of the patients studied.
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By GlobalDataA final decision on the approval is expected from the FDA by 26 April.
