The FDA has approved denosumab (Prolia) as a treatment to increase bone mass in prostate cancer patients at high risk for fracture undergoing androgen deprivation therapy (ADT) and women with breast cancer at high risk for fracture who are receiving aromatase inhibitor therapy.
Prolia is the first-and-only therapy approved by the FDA for cancer treatment-induced bone loss in patients undergoing hormone ablation therapy, according to the drug’s maker, Amgen.
The expanded indications for Prolia are based on two Phase 3 clinical trials: a three year, randomized, double-blind, placebo-controlled study involving 1,468 men with non-metastatic prostate cancer receiving ADT and a two-year, double-blind, placebo-controlled study involving 252 postmenopausal women with breast cancer undergoing aromatase inhibitor therapy.
The medication is contraindicated in patients with hypocalcemia, Amgen said in a press release. Pre-existing hypocalcemia must be corrected prior to initiating treatment.