Amgen announced that the FDA has approved Prolia (denosumab injection) 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. 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 with breast cancer receiving aromatase inhibitor therapy.
In men, bone mineral density (BMD) was significantly higher at the lumbar spine in patients treated with Prolia for two years compared with placebo (-1% placebo, +5.6% Prolia; P<0.0001). Additionally, after three years of treatment with Prolia, differences in BMD were 7.9% at the lumbar spine, 5.7% at the (total) hip and 4.9% at the femoral neck and the incidence of new vertebral fractures was 3.9% in the placebo-treated men compared with 1.5% for the Prolia-treated men, representing a relative risk reduction of 62% (P=0.0125). In women, BMD was higher at 12 months at the lumbar spine in patients treated with Prolia as compared with placebo (-0.7% placebo, +4.8% Prolia; P<0.0001). Additionally, after two years of treatment with Prolia differences in BMD were 7.6% at the lumbar spine, 4.7% at the (total) hip and 3.6% at the femoral neck.
Prolia is already indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
For more information call (877) 4-PROLIA or visit www.prolia.com.