Denosumab curbs bone loss from cancer therapy.
The approved indications are for increasing bone mass in women at high risk for fracture on adjuvant aromatase inhibitor therapy for breast cancer and in men at high risk for fracture on androgen deprivation therapy (ADT) for non-metastatic prostate cancer, the company's statement said.
Denosumab, a RANK ligand inhibitor, was first approved in June 2010 for treating postmenopausal women with osteoporosis at high risk of fracture and is marketed as Prolia.
In November 2010, denosumab was also approved for preventing skeletal-related events in patients with bone metastases from solid tumors. It is marketed as Xgeva and administered more frequently at a higher dose for this indication.
Approval of the new indications was based on phase III studies of these two groups of patients, according to Amgen. In an international study of almost 1,500 men with nonmetastatic prostate cancer who were being treated with ADT, bone mineral density at the lumbar spine after 2 years of treatment was significantly higher among men who had received denosumab compared with those who received placebo. After 3 years of treatment, the incidence of new vertebral fractures was 1.5% among those treated with denosumab, compared with 3.9% for those on placebo, a risk reduction of 62%, the company said.
In a study of 252 postmenopausal women with breast cancer under treatment with an aromatase inhibitor, bone mineral density at the lumbar spine was significantly higher among those treated with denosumab compared with those on placebo after 12 months of treatment, according to the statement.
Arthralgia and back pain were the most common adverse events associated with treatment in these two groups of patients. Hypocalcemia was also reported.
- From staff reports
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|Title Annotation:||NEWS FROM THE FDA|
|Publication:||Internal Medicine News|
|Date:||Oct 15, 2011|
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