FDA stalls Amgen's Xgeva sBLA for prevention of bone metastases

USA-based Amgen (Nasdaq: AMGN) revealed on Friday that the US Food and Drug Administration has issued a Complete Response Letter relating to its supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

Recently-launched Xgeva, which is already approved to prevent fractures in patients with advanced prostate cancer that has migrated to the bone, generated first-quarter 2012 sales of $153 million, up 14% over the last quarter of 2011. Amgen, the world’s largest biotech company, is seeking additional approval for use to postpone or prevent the cancer's spread.

The CRL states that the FDA cannot approve the application in its present form. The agency determined that the effect on bone metastases-free survival (BMFS) was of insufficient magnitude to outweigh the risks (including osteonecrosis of the jaw) of Xgeva in the intended population, and requested data from an adequate and well-controlled trial(s) demonstrating a favorable risk-benefit profile for Xgeva that is generalizable to the US population.