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FDA Approves Lenvatinib/Everolimus for Advanced RCC

Robert J. Motzer, MD

Robert J. Motzer, MD

The FDA has approved the combination of lenvatinib (Lenvima) and everolimus (Afinitor) as a treatment for patients with advanced renal cell carcinoma (RCC) following prior antiangiogeneic therapy, based on progression-free survival (PFS) and overall survival (OS) data from a phase II study.

In the trial, known as Study 205, the combination of lenvatinib and everolimus reduced the risk of progression or death by 63% compared with the mTOR inhibitor everolimus alone. Median progression-free survival (PFS) with the combination was 14.6 versus 5.5 months with everolimus (HR, 0.37; 95% CI, 0.22-0.62). There was a 33% reduction in the risk of death with the combination versus the single-agent everolimus.

Prior to the approval, the combination of lenvatinib and everolimus had received a breakthrough therapy designation as a treatment for RCC. The combination was approved earlier than anticipated, under the FDA's priority review program. Click here to read the full article at

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