Switzerland’s Novartis has pulled its application to extend the use of Zometa in Europe, says the continent’s regulator.

The European Medicines Agency noted that it has been formally notified by Novartis Pharma AG of its decision to withdraw the application to extend the marketing authorisation to include a new indication for Zometa (zoledronic acid), which was approved in March 2001 for the prevention of advanced bone cancer, as well as for the treatment of tumour-induced hypercalcaemia. Last December, the company applied to extend the use to include preventing fractures and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors.

However the company has now told the EMEA that the decision to withdraw its later application was based on the fact that the agency's Committee for Medicinal Products for Human Use had decided that the data provided by Novartis did not allow the CHMP to extend the indication. The agency added that more information about Zometa “and the state of the scientific assessment at the time of withdrawal of the new indication” will be made available in a question-and-answer document that will be published on the EMEA website after the next meeting of the CHMP on 10-13 December.