As expected (and as previously discussed on this site), Amgen has submitted a supplemental Biologics Licensing Application (sBLA) for denosumab (Xgeva®) for the prevention or the delay of the spread of prostate cancer to bone in men with castrate-resistant prostate cancer (CRPC).
The full details of this application to the U.S. Food & Drug Administration (FDA) are available in a media release issued by Amgen yesterday.
This request for an expanded indication is based on data from a randomized, double-blind, multi-center Phase III clinical trial in which outcomes after treatment with denosumab were compared to outcomes after treatment with a placebo in >1,400 men with CRPC. The study showed that treatment with denosumab extended bone metastasis-free survival by 4.3 months by comparison with treatment with placebo (29.5 versus 25.2 months, respectively). The results of this trial were originally presented at the annual meeting of the American Urological Association in May this year, as reported by The “New” Prostate Cancer InfoLink at that time.