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ODAC rejects expanded use for bone drug in men with prostate cancer
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The FDA’s Oncologic Drugs Advisory Committee rejected a request from Amgen to allow denosumab to be used as a preventive measure for men who have prostate cancer.
Denosumab (Xgeva) is approved to prevent fractures in patients whose cancer has spread to the bones. Amgen sought FDA approval to use the injectable drug in men with recurring prostate cancer that has not responded to other therapies and is at high risk for spreading to the bones.
The advisory committee rejected the request by a 12-1 vote.
Studies have demonstrated denosumab can slow the spread of the disease, but associated risks outweighed the drug’s benefit, committee members said.
An Amgen study enrolled 1,432 men with prostate cancer that had not spread to the bones and had not responded to prior therapies. Half of the participants were assigned to denosumab and half were assigned to placebo.
The patients assigned to denosumab had a median bone metastasis-free survival of 29.5 months, compared with 25.2 months for those assigned to placebo (P=0.028). However, there was no significant difference in OS between the two groups.
About 5% of patients developed osteonecrosis of the jaw. The dug also has been associated with hypocalcemia.
The FDA, which is not obligated to follow the advisory committee’s recommendation, is expected to make its decision on Amgen’s request by April 26.
Amgen officials said they will continue to discuss its data with the FDA.
“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,” Sean Harper, MD, senior vice president of global development and chief medical officer at Amgen, said in a press release. “Xgeva is the first agent to prolong bone metastasis-free survival and addresses this important unmet medical need.”
Denosumab also is sold under the brand name Prolia as an osteoporosis treatment.
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