Dr. Choueiri on FDA Approval of Lenvatinib Plus Everolimus in RCC

Toni K. Choueiri, MD, clinical director, Lank Center for Genitourinary Oncology, director, Kidney Cancer Center, senior physician, Dana-Farber Cancer Institute, comments on the FDA approval of the combination of lenvatinib (Lenvima) and everolimus (Afinitor) as a treatment for patients with advanced renal cell carcinoma (RCC) following prior anti–angiogeneic therapy.

Toni K. Choueiri, MD, clinical director, Lank Center for Genitourinary Oncology, director, Kidney Cancer Center, senior physician, Dana-Farber Cancer Institute, comments on the FDA approval of the combination of lenvatinib (Lenvima) and everolimus (Afinitor) as a treatment for patients with advanced renal cell carcinoma (RCC) following prior anti—angiogeneic therapy.

The approval is based on progression-free survival (PFS) and overall survival (OS) data from a phase II study, known as Study 205.

In the study, the combination of lenvatinib and everolimus reduced the risk of progression or death by 63% compared with the mTOR inhibitor everolimus alone. Median 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.

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