Eisai’s Kisplyx Licensed for New Cancer Drug Indication
Eisai has received a license from the European Commission for the anti-cancer agent, Kisplyx (lenvatinib), in combination with everolimus for adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor targeted therapy.
In Europe, lenvatinib has been designated as an orphan drug for thyroid cancer and is marketed as Lenvima for this indication. Renal cell carcinoma does not meet the criteria for orphan drug designation in Europe, according to Eisai. 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.