FDA Approval Sought for Zometa® for Advanced Breast 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 breast 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 breast cancer, prostate cancer, and lung cancer.

In the breast cancer trial, Novartis said Zometa was as effective and well tolerated as Aredia® (pamidronate disodium) -- the current standard of treatment - with the added convenience of a 15-minute infusion time versus two-to-24 hours for Aredia.

Other Sources: Novartis