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FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
Date:9/19/2011

THOUSAND OAKS, Calif., Sept. 19, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved two new indications for Prolia® (denosumab) as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.  In patients with prostate cancer, Prolia also reduced the incidence of vertebral fractures.  Prolia is the first-and-only therapy approved by the FDA for cancer treatment-induced bone loss in patients undergoing hormone ablation therapy.

Aromatase inhibitors are often used in patients with breast cancer to prevent recurrence of disease, and androgen deprivation therapy is often used in patients with prostate cancer to prevent or control recurrent disease. These treatments reduce hormone levels, leading to bone loss and an increased risk of fracture.

"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," said Matthew Smith, M.D., Ph.D., director of the Genitourinary Malignancies Program at Massachusetts General Hospital Cancer Center, Boston. "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."

The expanded indications for Prolia are based on two Phase 3 clinical trials: a three year, randomized, double-blind, placebo-controlled, multinational study involving 1,468 men with non-metastatic prostate cancer undergoing androgen deprivation therapy, and a two year, double-blind, placebo-controlled, multinational study involving 252 postmenopausal women wi
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