EU approval for Eisai's Kisplyx in new indication of kidney cancer

Japanese pharma major Eisai (TYO 4523) has received approval from the European Commission for anticancer agent Kisplyx (lenvatinib) in combination with everolimus (Novartis' Afinitor) for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy.

Following the USA, Europe marks the second region where lenvatinib has been licensed for the advanced renal cell carcinoma indication. The European Medicines Agency’s advisory committee recommended approval of the drug back in July.

In Europe, lenvatinib has been designated as an orphan drug for thyroid cancer and is marketed as Lenvima for this indication. In Europe, renal cell carcinoma does not meet the criteria for orphan drug designation. Accordingly, under European regulations, any licensed medicine that previously received orphan drug designation for an indication and subsequently receives license for a non-orphan indication must be marketed under a different trade name. As such, lenvatinib will be marketed as Kisplyx in the European Union for the indication covering renal cell carcinoma.