FDA Approves Zometa for Cancer-Related Bone Complications

EAST HANOVER, New Jersey—The US Food and Drug Administration has approved the Novartis drug Zometa (zoledronic acid for injection) for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.

These solid tumors include prostate cancer, lung cancer, breast cancer, and other solid tumor types. In prostate cancer, patients should have progressed after treatment with at least one hormonal therapy.

The trials that led to the approval mark the first time any bisphosphonate has shown efficacy in treating bone complications in patients with prostate cancer, lung cancer, and other solid tumors, Novartis said in a news release. Further, Zometa offers patients, nurses, and clinicians a convenient 4 mg, 15-minute infusion time.

Novartis submitted the new drug application (NDA) for the bone metastases indication to the FDA in August 2001, and in October 2001, the NDA received a priority review designation. Zometa was previously approved for the treatment of hypercalemia of malignancy.

The approval is based on data from three large international clinical trials evaluating more than 3,000 patients with prostate, lung, and breast cancer, and other solid tumors, and multiple myeloma. In two placebo-controlled studies in patients with bone metastases from prostate cancer or other solid tumors, both the number of patients with skeletal events and the time to first skeletal-related event were decreased, compared with placebo.