Novartis has suffered a setback with the news that its bonedrug Zometa has failed in a study as a potential treatment for early breast cancer.

Resultsfrom the second interim analysis of the 3,360-patient Phase III AZURE trialshow that Zometa (zoledronic acid) did not demonstrate a disease-free survivaladvantage when added to standard adjuvant chemotherapy and/or hormonal therapyin pre- and postmenopausal women with early breast cancer. Based on the data,presented at the San Antonio Breast Cancer Symposium in Texas, currentapplications in the USA and the European Union for adjuvant treatment in earlybreast cancer will be withdrawn.

Novartissaid it will evaluate future plans for Zometa in breast cancer based on thesenew data but it was not all bad news. The Basel-headquartered firm also notedthat in a preplanned analysis, a benefit in disease free survival and overallsurvival was seen in women with well-established menopause in the Zometa arm.

Thedrug is approved in more than 100 countries for the reduction or delay of bonecomplications in multiple myeloma and across a broad range of metastaticcancers prostate, lung and other solid tumors) involving bone, as well as forthe treatment of hypercalcaemia of malignancy.