FDA Gives Zometa Priority Review for Bone Metastases

EAST HANOVER, NJ—In a news release, Novartis announced that the FDA has granted priority review to its intravenous bisphosphonate Zometa (zoledronic acid for injection) for the treatment of bone metastases associated with a broad range of tumor types, including multiple myeloma and prostate, lung, and breast cancer. The application is based on data from three large international clinical trials evaluating more than 3,000 patients. Zometa previously received FDA approval for use in treating tumor-induced hypercalcemia.

An international phase III study (The Cancer Journal Sept 2001) compared the efficacy of a 15-minute infusion of Zometa 4 mg with that of a 2-hour infusion of pamidronate disodium (Aredia) 90 mg, given every 3 to 4 weeks for 12 months, in 1,648 patients with stage III multiple myeloma or advanced breast cancer and at least one bone lesion.

At month 13, the proportion of patients having at least one skeletal-related event (SRE) was similar in both groups: 44% of the Zometa patients vs 46% of the pamidronate group. In addition, the median time to first SRE was approximately 1 year in both groups. The two agents were equally well tolerated.

The authors concluded that the 15-minute infusion time of Zometa offers benefits to clinicians and patients.