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news.Amgen has filed a supplemental biologics license application (sBLA) to widen the indication of XGEVA (denosumab), as a treatment to reduce the risk of developing bone metastases in men with castrate-resistant prostate cancer, with the US Food and Drug Administration (FDA).
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The company’s sBLA is supported by the results of a Phase 3 Study (‘147) investigating XGEVA versus placebo in 1,432 men with castrate-resistant prostate cancer.
The results of the trial suggested that XGEVA prolonged bone metastasis-free survival by more than four months in comparison to placebo (29.5 versus 25.2 months, respectively) in men with castrate-resistant prostate cancer that had not yet spread to the bone.
Amgen Research and Development executive vice president Roger Perlmutter said the successful outcome of this study provides clinical evidence supporting the view that tumors activate the RANK Ligand pathway to penetrate bone.