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Phase III Data Published in Lancet Show Novartis Drug Zometa® Improves Overall Survival in Newly Diagnosed Multiple Myeloma Patients
Date:12/3/2010

EAST HANOVER, N.J., Dec. 3, 2010 /PRNewswire/ -- A newly published study in the Lancet suggested that a first-line treatment regimen including Zometa® (zoledronic acid) significantly improved overall survival (OS) and progression-free survival (PFS) in newly diagnosed multiple myeloma patients compared with a regimen that included oral clodronate. The impact on survival was independent of the effect of Zometa on bone complications (also known as skeletal-related events or SREs) (1,2).

The published results are from Medical Research Council (MRC) Myeloma IX, a large, randomized, Phase III clinical trial of nearly 2,000 patients with multiple myeloma (1). These results were initially reported at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, in June 2010.

At a median follow-up of 3.7 years, Zometa significantly reduced the risk for death by 16% (hazard ratio [HR] 0.842; 95% confidence interval [CI] 0.74-0.96; P=0.0118) and the relative risk for PFS events by 12% (HR 0.88; 0.80-0.98; P=0.0179) compared with oral clodronate. In addition to demonstrating superiority to clodronate on survival endpoints, Zometa was significantly superior to clodronate in the prevention of SREs associated with multiple myeloma, regardless of SRE history at baseline (1).

More than 750,000 cases of multiple myeloma are diagnosed each year worldwide, with a median overall survival of three to five years (3). Nearly 95% of advanced stage multiple myeloma patients have bone disease and half of them will experience SREs (e.g., pathologic fractures, radiation or surgery to bone, spinal cord compression) if not treated (4,5).

"As a hematologist who treats patients with multiple myeloma, the survival benefit demonstrated by Zometa in this study is very encouraging," said Professor Gareth Morgan, Head of Haemato-oncology at The Royal Marsden and The Institute of Cancer Research, UK and one of the study's lead in
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SOURCE Novartis Pharmaceuticals Corporation
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