ARTICLE | Clinical News

Novartis withdraws Zometa applications after Phase III miss

December 10, 2010 12:44 AM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) said it will withdraw regulatory applications in the U.S. and EU for Zometa zoledronic acid for the adjuvant treatment of early breast cancer in premenopausal women after the IV bisphosphonate missed the primary endpoint in the Phase III AZURE trial. Adjuvant treatment with Zometa plus standard chemotherapy and/or hormonal therapy did not significantly improve disease-free survival vs. standard therapy alone after a median follow-up of 59 months. The open-label, international trial enrolled 3,360 pre- and post-menopausal women with stage II or III breast cancer. Data were presented at the San Antonio Breast Cancer Symposium. ...