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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

th breast cancer receiving aromatase inhibitor therapy.(i)

In men, bone mineral density (BMD) was significantly higher at the lumbar spine in patients treated with Prolia for two years compared to placebo (-1.0 percent placebo, +5.6 percent Prolia; treatment difference 6.7 percent [95 percent CI: 6.2, 7.1]; P<0.0001). Additionally, after three years of treatment with Prolia, differences in BMD were 7.9 percent at the lumbar spine, 5.7 percent at the (total) hip and 4.9 percent at the femoral neck and the incidence of new vertebral fractures was 3.9 percent in the placebo-treated men compared to 1.5 percent for the Prolia-treated men, representing a relative risk reduction of 62 percent (P=0.0125).

In women, BMD was higher at 12 months at the lumbar spine in patients treated with Prolia as compared to placebo (-0.7 percent placebo, +4.8 percent Prolia; treatment difference 5.5 percent [95 percent CI: 4.8, 6.3]; P<0.0001). Additionally, after two years of treatment with Prolia differences in BMD were 7.6 percent at the lumbar spine, 4.7 percent at the (total) hip and 3.6 percent at the femoral neck.

The most common (per patient incidence > 10 percent) adverse reactions reported with Prolia in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer are arthralgia and back pain.  Pain in extremity and musculoskeletal pain have also been reported in clinical trials.  Additionally, in Prolia-treated men with non-metastatic prostate cancer receiving androgen deprivation therapy, a greater incidence of cataract adverse events was reported. Hypocalcemia was reported in Prolia-treated patients.

About Prolia

Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).

Prolia is approved in the U.S. for the treatment of postmenopausal
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SOURCE Amgen
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