The market for Amgen Inc's Prolia has been expanded for two new uses after the US Food and Drug Administration approved the osteoporosis drug to be used for treating bone loss among patients with breast cancer and non-metastatic prostate cancer.
The drug was initially approved by the FDA last year to treat osteoporosis among post-menopausal women. In July 2010 the FDA gave a priority review for Prolia with regard to its ability to reduce skeletal-related events in cancer patients with bone metastases.
The latest approval by the health regulator allows it to be used in treating bone loss among women who have undergone adjuvant aromatase inhibitor therapy for breast cancer and men who have opted for hormone therapy to recover from prostate cancer.
The new approval is based on the results of two phase III studies that showed improved bone mineral density (BMD) with this molecule in patients with prostate cancer and breast cancer.