Amgen says Xgeva first drug to prevent spread of bone cancer in prostate cancer patients

Amgen (Nasdaq: AMGN), the world’s largest biotech company, has announced primary results of a pivotal Phase III trial (Study 147) demonstrating that Xgeva (denosumab) significantly increased bone metastasis-free survival for more than four months in men with castrate-resistant metastatic prostate cancer that has not yet spread to bone. Full results of the '147 study were presented for the first time today in a late-breaking plenary session at the American Urological Association (AUA) 2011 Annual Meeting in Washington DC.

If approved by the Food and Drug Administration for this additional indication, which the company says it will seek to obtain by the end of the second quarter, the use of denosumab injections will be the first successful treatment for bone metastasis prevention in prostate cancer. With effective therapies now in place for both early (castrate-sensitive) prostate cancer and advanced (castrate-resistant) prostate cancer, there is a gap in the treatment plan for those patients who are castrate-resistant but have not yet developed metastatic disease, the company notes. Bone is the most common place for prostate cancer to spread; up to 90% of men with prostate cancer will experience bone metastases.

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