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The European Commission has approved Kisplyx (lenvatinib) for the treatment of people with advanced renal cell carcinoma (RCC). Lenvatinib is a new, more potent tyrosine kinase inhibitor, that is given in combination with everolimus for the treatment of people with advanced RCC following the failure of one prior vascular endothelial growth factor (VEGF) targeted therapy.
Lenvatinib is already available in Europe under the tradename Lenvima for the treatment of adults with advanced or metastatic thyroid cancer, which is not responding to radioactive iodine.
The European Commission approval for the second-line treatment of advanced RCC was based on data from a phase II clinical trial comparing lenvatinib with everolimus. In this trial, lenvatinib plus everolimus significantly extended progression-free survival (PFS); median PFS was 14.6 months in the group taking the combination versus 5.5 months for those taking everolimus alone.