FDA Expands Approval for Denosumab
September 19, 2011 -- On Friday, September 16, 2011, the Food and Drug Administration (FDA) approved denosumab (Prolia) to increase bone mass in non-metastatic prostate cancer patients undergoing androgen deprivation therapy (ADT). Patients undergoing ADT tend to be at high-risk for fractures, including fractures of the spine. With denosumab injections, patients may reduce the risk of these fractures.
Matthew Smith, MD, PhD, director of the Genitourinary Malignancies Program at Massachusetts General Hospital Cancer Center, Boston has been a Prostate Cancer Foundation (PCF) funding recipient since 1997 for his work in improving prostate cancer survivorship. PCF has invested more than $1.8 million in Dr. Smith and his team’s critical research projects on denosumab and treatment sciences on improving survivorship. The more than $1.8 million in funding support for Smith and denosumab from the Prostate Cancer Foundation came from peer-reviewed, non-corporate academic grants starting in 1997.
Dr. Smith was involved in the design of the registrational clinical investigations for Prolia. Denosumab is manufactured by Amgen pharmaceuticals.
Denosumab is also approved by the FDA for additional indications. Prolia was approved by the FDA on June 1, 2010 for the treatment of postmenopausal women with osteoporosis who are considered to be at high-risk for fractures. In November 2010, the FDA approved Prolia (Xgeva) to help prevent skeletal-related events (SREs) in prostate cancer patients treated with ADT whose cancer had metastasized to bone.