Pharmaceutical giant Novartis has announced that following a priority review, the US FDA has approved an update to the indications on Gleevec tablets to include a recommendation of 36 months of Gleevec treatment following surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial.
Such a regimen has shown toimprove both recurrence-free survival (RFS) and overall survival (OS) in this patient population compared to taking Gleevec for 12 months.
FDA approval comes on the heels of data from an international, multicenter, open-label, Phase III clinical trial pitting 36 months of treatment against 12. The former outperformed the latter in both metrics.
Said the President of Novartis Oncology Herve Hoppenot, "This approval represents another important step in the progress of KIT+ GIST treatment that began a decade ago when Gleevec was first approved to treat metastatic KIT+ GIST. With the significant survival benefit resulting from three years of adjuvant treatment, GIST patients now have a more effective regimen to help manage their disease."
Source: FDA
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