The Food and Drug Administration's Advisory Committee for Reproductive Health Drugs voted that the benefits of denosumab to treat osteoporosis in postmenopausal women outweighed its risks, but the committee did not support use of the drug to prevent osteoporosis.
Denosumab (Prolia) manufacturer Amgen Inc. also was seeking approval of the human IgG2 monoclonal antibody to treat and prevent bone loss in women with breast cancer receiving hormone ablation therapy and to treat and prevent bone loss in men with prostate cancer receiving androgen deprivation therapy. The committee declined to support most of those uses, primarily because of concerns about long-term safety. Its members did vote 9-4 that the benefits outweighed the risks in treating bone loss in prostate cancer.
The committee did not formally vote on approval for any of the indications but took a series of votes on the risks and benefits of denosumab.
For osteoporosis prevention, advisory committee members expressed particular concern about exposing otherwise healthy women to a therapy that had been shown to have a slightly higher risk of causing serious skin infections and neoplasms. Dr. Scott Emerson, a biostatistician from the University of Washington, Seattle, said he could not say the benefits outweighed the risks, “because there's a lot of uncertainty in this low-risk population.”
Committee members also said that Amgen had not shown that denosumab did not affect the underlying disease or tumor progression when used in the breast cancer setting. Dr. Lawrence M. Nelson, a panel member and researcher at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, said he could not support use of the drug in breast cancer, “because of concerns about the need for more data on how this affects the primary disease.”
But the committee was more enthusiastic about Amgen's studies in the prostate cancer setting, saying that the company had proved, at least in treating bone loss, that denosumab reduced fracture risk.
The FDA generally follows the advice of its panels.