Approval of denosumab for extension of metastasis-free survival in the USA?


According to a media release from Amgen earlier today, the U.S. Food & Drug Administration (FDA) has indicated that a decision will be made by April 26, 2012 about the requested expansion of the indication for denosumab (Xgeva®) to include the prevention of bone metastases in men with non-metastatic, castration-resistant prostate cancer.

For details of the data on the use of denosumab to prevent the development of bone metastasis, see our earlier commentary from May this year. The bottom line was that treatment with denosumab extended metastasis-free survival by 4.2 months compared to treatment with a placebo.

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