FDA approves Lenvima in combination with Everolimus for the treatment of patients with advanced renal cell carcinoma

The U.S. Food and Drug Administration (FDA) very recently approved Lenvima (lenvatinib), a multiple receptor tyrosine kinase inhibitor, in combination with Everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an anti-angiogenic therapy. This approval was based on the impressive results of a phase 2 study, in which the combination of Lenvima and Everolimus demonstrated a substantial improvement in progression-free survival and clinically meaningful overall survival when compared with Everolimus alone, the standard of care for patients with aRCC following prior anti-angiogenic therapy.

  • Motzer RJ et al., 2015. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncol. PMID: 26482279
  • Lenvatinib in combination with everolimus. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm501070.htm May 13, 2016. Accessed June 1, 2016.

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