FDA approves two new indications for Amgen's Prolia
THOUSAND OAKS, Calif. — The Food and Drug Administration has approved two new uses for a drug made by Amgen, the drug maker said Monday.
Amgen announced the approval of the biotech drug Prolia (denosumab) for increasing bone mass in men and women who are at risk of fractures due to hormone ablation treatments they are receiving for prostate and breast cancer, respectively.
"Bone loss and fractures are recognized adverse effects of hormone ablation therapies, but we have not had an approved treatment option to prevent these problems for our patients," Massachusetts General Hospital Cancer Center genitourinary malignancies program head Matthew Smith said. "Prolia now gives us the ability to reduce the risk of bone loss and fractures, allowing patients to continue their treatment and their fight against cancer."