FDA Approval Sought for Zometa® for Advanced Prostate Cancer

Novartis announced that it has submitted an application to the U. S. Food and Drug Administration seeking marketing authorization for Zometa® (zoledronic acid) for treating metastases associated with spread of prostate cancer to the bone.

Zometa is a new generation intravenous bisphosphonate just approved by the FDA for the treatment of hypercalcemia of malignancy (HCM), the most common life-threatening metabolic complication of cancer.

The new submission for FDA review is based on data from three trials conducted to evaluate the efficacy and tolerability of bisphosphonates in treating bone metastases.of more than 3,000 patients with prostate cancer, lung cancer and breast cancer.

In the prostate cancer trial, Novartis said Zometa demonstrated clear efficacy when compared to a placebo in the treatment of bone metastases. Over the 15-month evaluation period of this trial, patients receiving Zometa were less likely to experience skeletal related events (eg, a fracture) compared that those receiving a placebo. Further, patients on Zometa delayed the onset of the first skeletal related event when compared to placebo, a spokesman said.

Other Sources: Novartis