It was announced on September 19, 2011, that two new indications for Prolia® (denosumab) were approved by the U.S. Food and Drug Administration (FDA). One indication allows for building bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer and with an increased likelihood of fracture. The other indication is for increasing bone mass in men being treated with androgen deprivation therapy for nonmetastatic prostate cancer and at great risk for fracture. For patients receiving hormone ablation therapy with cancer treatment-induced bone loss, denosumab is the first and only treatment approved by the FDA.
To prevent disease recurrence, aromatase inhibitors are often used in patients with breast cancer, and androgen deprivation therapy is often used in patients with prostate cancer. These two therapies, however, reduce hormone levels, lead to bone loss, and result in an increased risk of fracture.
The expanded indications for denosumab are based on two phase 3 clinical trials:
- 3-year, randomized, double-blind, placebo-controlled, multinational study involving 1468 men with nonmetastatic prostate cancer receiving androgen deprivation therapy
- 2-year, double-blind, placebo-controlled, multinational study involving 252 postmenopausal women with breast cancer undergoing aromatase inhibitor therapy
“Bone loss and fractures are recognized adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients,” said Matthew Smith, MD, PhD, director of the Genitourinary Malignancies Program at Massachusetts General Hospital Cancer Center, Boston. “Prolia now gives us the ability to reduce the risk of bone loss and fractures, allowing patients to continue their treatment and their fight against cancer.”
Source: Amgen.