FDA expands approval of Amgen's Prolia

The FDA on Monday expanded approval of Amgen's Prolia (denosumab) to increase bone mass in women with breast cancer and in certain men with non-metastatic prostate cancer. The company noted that Prolia is the first drug to garner US clearance for cancer treatment-induced bone loss in patients undergoing hormone ablation therapy.

Specifically, the agent is authorised for use in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy (ART) for breast cancer and in men at high risk for fracture with prostate cancer who are being treated with androgen deprivation therapy (ADT).

The approvals were based on data from two Phase III studies. In the first trial, which involved 1468 men with non-metastatic prostate cancer undergoing ADT, bone mineral density was significantly higher at the lumbar spine after two years in patients treated with Amgen's drug versus placebo. After three years of treatment with Prolia, differences in bone mineral density were 7.9 percent at the lumbar spine, 5.7 percent at the total hip and 4.9 percent at the femoral neck. In addition, the incidence of new vertebral fractures was 62 percent lower for the Prolia-treated men.

In the second study, which involved 252 postmenopausal women with breast cancer receiving ART, patients given Amgen's therapy had higher bone mineral density at the lumbar spine at 12 months compared to placebo. After two years of treatment with Prolia, differences in bone mineral density were 7.6 percent at the lumbar spine, 4.7 percent at the total hip and 3.6 percent at the femoral neck.

Prolia was approved by US regulators in 2010 to treat osteoporosis in post-menopausal women at increased risk of fractures. The drug garnered sales of $44 million in the second quarter, exceeding expectations after falling short of analyst estimates in the three previous quarters. Analysts have suggested that sales of the product may reach nearly $1.2 billion in 2014.




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