FDA Grants Breakthrough Therapy Designation to Lenvatinib for Metastatic Renal Cell Carcinoma


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The U.S. Food and Drug Administration (FDA) granted lenvatinib (Lenvima) Breakthrough Therapy designation for investigational use in patients with advanced or metastatic renal cell carcinoma who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy.

Lenvatinib is a multiple receptor tyrosine kinase inhibitor currently indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine–refractory differentiated thyroid cancer.

Clinical Trial Results

Lenvatinib was designated as a Breakthrough Therapy based on results of a phase II open-label, multicenter study involving 153 patients who were previously treated with a VEGF-targeted therapy and randomly assigned 1:1:1 to receive lenvatinib and everolimus (Afinitor), lenvatinib, or everolimus. Nearly all patients (99%) had received one prior VEGF-targeted therapy, 1% had received two prior VEGF-targeted therapies, and 18% had received prior immunotherapy.

The results of this study were presented in an oral presentation at the 2015 ASCO Annual Meeting. Patients receiving lenvatinib plus everolimus had a median progression-free survival of 14.6 months, a 9.1-month improvement over everolimus alone (hazard ratio = 0.40, P < .001). In addition, the highest overall response rates were observed in the combination arm (43%, compared with 27% with lenvatinib alone and 6% with everolimus alone), with a median duration of response of 13.1 months. ■


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