Novartis gets Zometa approvable letter

Switzerland's Novartis is in labelling discussions with the US Food and Drug Administration for the long-term use of Zometa (zolendronic acid) in patients with advanced cancer that has spread to the bone, after receiving an approvable letter last week. Novartis filed for approval of the new indication in October last year, including long-term data of up to two years showing the drug's efficacy in treating cancer related complications of the bone, including bone pain, spinal cord compression and hypercalcaemia. The labelling for Zometa, which reaped more than $180 million dollars during the first half of the year, currently includes one-year data. Zometa is currently licensed in more than 60 countries to prevent skeletal events in patients with advanced cancers involving the bone, including multiple myeloma, prostate cancer and breast cancer. The European Union medicines authority gave its nod for the labelling to include data on long-term treatment back in June [[12/06/03e]], and Novartis will be hoping the FDA follows suit once labelling issues have been resolved.