FDA submissions made for two therapies to curb bone loss in prostate cancer

Two drugs aimed at stemming bone loss in men with prostate cancer have moved closer to FDA approval.

Amgen Inc. has submitted a biologics license application with the FDA for denosumab, an investigational RANK ligand inhibitor for the treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The submission contains data from six phase III trials involving more than 11,000 patients.

Two phase III studies with fracture endpoints demonstrated the drug’s ability to reduce fracture, and all six studies showed its ability to increase bone mineral density at the skeletal sites measured, according to Amgen.

In related news, GTx, Inc., has submitted a new drug application with the FDA for toremifene, 80 mg, an oral selective estrogen receptor modulator for the prevention of bone fractures in men with prostate cancer undergoing androgen deprivation therapy.

The submission is supported by results from a 2-year, double blind, placebo-controlled, randomized phase III clinical trial of 1,382 men with advanced prostate cancer on ADT. Toremifene, 80 mg, met the primary endpoint, a reduction in new morphometric vertebral fractures compared with placebo, as well as other key secondary endpoints related to estrogen deficiency side effects of ADT.