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Novartis Zometa

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pooled results of two pivotal studies show improved efficacy for patients with tumor-induced hypercalcemia treated with zoledronic acid versus Novartis' Aredia (pamidronate), according to data presented at May's American Society of Clinical Oncology meeting. Complete response was shown in 69.7% of Aredia patients vs. 88.4% of Zometa 4 mg patients (p=0.002) and 86.7% of Zometa 8 mg patients (p=0.015) by day 10. CR was defined as corrected serum calcium levels of £ 10.8 mg/dL (2.7 mmol/L). Zometa also showed superiority in median time to relapse and median duration of complete response. Zometa's NDA is receiving a priority review with a user fee goal in late Jun

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