FDA Rejects Bone Drug Bid for Metastasis Prevention
WASHINGTON -- The FDA has turned down an application to expand indications for denosumab (Xgeva) to include prevention of bone metastases in men with castration-resistant prostate cancer.
In a Complete Response Letter to drug developer Amgen, the FDA characterized evidence of improved bone metastasis-free survival as being insufficient to offset concern about potential adverse effects of treatment, including osteonecrosis of the jaw.
In February, the agency's Oncologic Drugs Advisory Committee the expanded indication, in large part because of the osteonecrosis risk.
Denosumab currently has an indication for prevention of skeletal-related events in patients with bone metastases from solid tumors.
The indication specifically excludes metastases from multiple myeloma, for which efficacy data remain insufficient.
In a , Amgen officials said the letter cites a need for data from adequate and well-controlled trials to demonstrate a favorable risk-benefit profile for denosumab, generalizable to the U.S.
"We are reviewing the complete response letter and will work with FDA to determine any next steps," Amgen executive vice president Sean E.
"The FDA's action today does not impact the approved indication of Xgeva in the prevention of skeletal-related events in men with bone metastases from prostate cancer, which was acknowledged by the FDA and the advisory committee members who discussed the application."
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