FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Men with Prostate Cancer Undergoing ADT

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved two new indications for Prolia® (denosumab) as a treatment to increase bone mass in men receiving androgen deprivation therapy (ADT) for non-metastatic prostate cancer. Men receiving ADT are at high risk for developing fractures, including vertebral fractures, which can cause paralysis. "Bone loss [...]

Denosumab delays the Spread of Prostate Cancer to the Bones, But it Doesn’t Extend Life!

Results from a recent clinical trial indicate that denosumab delayed the spread of prostate cancer metastases bones, however it did not prolong the lives of men. […]

FDA Questions Denosumab Safety in Advisory Meeting Documents

Just revealed in briefing documents which were released in advance of a scheduled Thursday meeting of the FDA’s Advisory Committee for Reproductive Health Drugs, which will be considering whether to recommend denosumab for approval, are significant concerns that denosumab, the investigational biologic drug for osteoporosis, may increase risk of serious infections through its activity against [...]