Zometa two-year data "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Novartis' Zometa (zoledronic acid) sNDA to include two-year follow-up data on patients with bone metastases from advanced cancers is "approvable" Aug. 15, "pending future labeling discussions," the firm says. The long-term data comes from three pivotal trials, ranging in duration from nine to 12 months, that supported Zometa's February 2002 approval for multiple myeloma and bone metastases of solid tumors (1Pharmaceutical Approvals Monthly Nov. 1, 2002, p. 9). Novartis estimates that 500,000 patients worldwide have received Zometa...