The European Commission has stamped its approval on the use of Eisai's Kisplyx to treat advanced kidney cancer.
The approval allows the drug's administration alongside everolimus (Novartis' Afinitor) in adults with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF) targeted therapy.
Lenvatinib is an oral molecular tri-specific targeted therapy with potent selectivity, says Eisai. The drug is already available in Europe under the tradename Lenvima adults with progressive, locally advanced or metastatic differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Approval for RCC was based on data from a Phase II showing that the drug significantly extended progression-free survival (PFS) when added to treatment with everolimus; those given the combination regimen experienced a median PFS of 14.6 months versus 5.5 months for those taking everolimus alone.
Hilary Glen, Consultant Medical Oncologist, Beatson West of Scotland Cancer Centre, Scotland, UK, said earlier this year: "The current outlook for people with this aggressive cancer is poor, and therefore the potential of lenvatinib is very exciting indeed".
Following the United States, Europe marks the second region where lenvatinib has been licensed for the advanced renal cell carcinoma indication.
The disease comprises more than 90 percent of all malignancies of the kidney, affecting around 115,000 in Europe and 58,000 in the US.