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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.

Renal cell carcinoma is the most common type of kidney cancer, representing about 90% of cases in the United States. Approximately 20% to 30% of patients with renal cell carcinoma will have metastatic (stage IV) disease at diagnosis, and as many as 40% will demonstrate metastasis after primary surgical treatment for localized disease. The prognosis for these patients is poor, with a 5-year survival rate ranging from 5% to 10%.

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 treatment.

The results of this study were presented in an oral presentation at the 2015 American Society of Clinical Oncology (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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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