May 06, 2011
Afinitor Gains Approval for Advanced Pancreatic Neuroendocrine TumorsNovartis announced that Afinitor (everolimus tablets) has been approved for the treatment of progressive neuroendocrine tumors of pancreatic origin in patients with unresectable, locally advanced or metastatic disease. This approval was based on data from the Phase 3, prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors) trial, that showed that treatment with Afinitor more than doubled the time without tumor growth (median 4.6–11 months) and reduced the risk of cancer progression by 65% when compared with placebo (hazard ratio=0.35 [0.27–0.45]; P<0.001). A consistent improvement in progression-free survival was seen with Afinitor in all patient subgroups.
Afinitor, a mTOR kinase inhibitor, is already indicated for the treatment of advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib and for subependymal giant cell astrocytoma associated with tuberous sclerosis in patients who require therapeutic intervention but are not candidates for curative surgical resection.
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