Novartis has confirmed it will pull a submission to get the label expanded on its bone drug Zometa in Europe, after the regulator required more data.
The European Medicines Agency says it has been formally notified by Novartis of its decision to withdraw an application for an extension of a centralised marketing authorisation for Zometa (zoledronic acid). The Swiss major was looking to get approval expanded to include the adjuvant treatment of hormone receptor-positive early breast cancer in premenopausal women for whom hormonal therapy is recommended.
The withdrawal of the submission was due to the EMA’s Committee for Medicinal Products for Human Use’s view that the data provided in support of the application so far would not allow it to recommend approval.
Zometa was first authorised in the European Union in March 2001 and is currently approved for the prevention of skeletal related events in patients with advanced malignancies involving bone, as well as for the treatment of tumour-induced hypercalcaemia.
The move comes days after results from the second interim analysis of the 3,360-patient Phase III AZURE trial showed that Zometa did not demonstrate a disease-free survival advantage when added to standard adjuvant chemotherapy and/or hormonal therapy in pre- and postmenopausal women with early breast cancer.
More information about Zometa and the state of the scientific assessment at the time of withdrawal will be published on the EMA website after the next CHMP meeting on 17 -20 January.
