1 February 2012 - Swiss pharmaceutical group Novartis (VTX:NOVN) said on Wednesday that the US Food and Drug Administration (FDA) had approved a change in the label of the company's Gleevec (imatinib mesylate) tablets to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumours (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial.

The FDA approval was based on the results from an international, multicenter, open-label, Phase III clinical trial, which showed that 36 months of Gleevec treatment significantly prolonged recurrence-free survival (RFS) compared to 12 months of Gleevec treatment, which was a 54% reduction in the risk of recurrence. Moreover, 36 months of Gleevec treatment resulted in a 55% lower risk of death compared to one year of treatment. The median time of follow-up was 42 months for RFS and 48 months for overall survival.