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Novartis receives FDA nod for Gleevec drug label change

PBR Staff Writer Published 02 February 2012

The US Food and Drug Administration (FDA) has approved Novartis Gleevec (imatinib mesylate) tablets label recommending 36 months of treatment for KIT (CD117)-positive gastrointestinal stromal tumors (GIST) patients after surgery.

The FDA has also agreed that all accelerated post-approval commitments for the indication have been met, which confirms the clinical benefit of adjuvant treatment with Gleevec.

The approval was based on data from an open-label, international, multicenter Phase III trial.

Study showed that 36 months of Gleevec treatment significantly prolonged RFS compared to 12 months of Gleevec treatment, which was a 54% reduction in the risk of recurrence (p<0.0001).

In addition, 36 months of Gleevec treatment resulted in a 55% reduction in the risk of death compared to one year of treatment (p=0.0187), the company said.

The median time of follow-up was 42 months for RFS and 48 months for OS.

Novartis Oncology president Herve Hoppenot said the approval represents important step in the progress of KIT+ GIST treatment.

"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," Hoppenot added.

In August 2011, the US National Comprehensive Cancer Network (NCCN) updated to include new adjuvant treatment duration in patients with KIT+ GIST.