Denosumab headlines may be confusing to many people reading the news. Previously, this drug was covered in an issue of The Essential Guide to Medical News (visitwww.EssentialGuideToPrescriptionDrugs and go to products) and was named Prolia for treating osteoporosis after menopause. It offers a different way of working than existing osteoporosis treatments (RANK Ligand inhibitor) and also avoids the heartburn/GERD problems of the bisphosphonate (Fosamax, Actonel, Boniva) family.
On November 19th, the FDA approved THE SAME MEDICINE, denosumab in higher dose and allowed the brand name Xgeva. These higher doses in oncology help prevent Skeletal Related Events (SREs) which include bone pain and fractures. When cancer starts in the prostate or breast or even other sites, spread of the cancer to the bone is a major problem and causes extreme pain which is difficult to relieve. Safety and effectiveness of Xgeva were studied in more than 5,700 patients with breast cancer, prostate cancer and other cancers and compared Xgeva to Zometa (zoledronic acid) and Aredia (pamidronate) in three studies.
For breast or prostate cancers, Xgeva worked better than Zometa in delaying SREs and had a reasonable balance of benefit and potential side effects. Xgeva lead to lowered blood calcium levels in some patients and rarely caused osteonecrosis of the jaw bone in these higher, more frequent doses used in oncology.
The latest study reported was called the 147 study. This involved more than 1,400 men with castrate resistant prostate cancer. The study showed that when compared to an inactive (placebo) treatment, the middle (median) of those studied gained 4.2 months of survival without spread (metastasis) of the cancer to the bone.
While one drug with two names may be somewhat confusing, it appears to offer significant benefits and quality of life improvement for patients with osteoporosis AND in higher dose for those with some kinds of cancers.