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FDA Approves Everolimus for GI, Lung NETs

Dr. Richard Pazdur

James C. Yao, MD

The FDA has approved everolimus (Afinitor) for the treatment of adult patients with progressive, well-differentiated non-functional, locally advanced or metastatic gastrointestinal (GI) or lung neuroendocrine tumors (NET), based on findings from the phase III RADIANT-4 trial.

In the study, median progression-free survival (PFS) was 11 months with everolimus versus 3.9 months for placebo. This represented a 52% reduction in the risk of progression or death for everolimus compared with placebo (HR, 0.48; 95% CI, 0.35-0.67; P <.001). Median PFS by investigator assessment with everolimus was 14.0 versus 5.5 months with placebo (HR, 0.39; 95% CI, 0.28-0.54; P <.001).

“We found a statistically significant 52% reduction in the risk of progression or death in favor of everolimus and also a clinically meaningful 2.8 fold improvement in PFS,” said lead investigator James Yao, MD, chair of the Department of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, when he presented the data at the 2015 European Cancer Congress. Click here to read the full article at

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