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Eisai's lenvatinib latest of FDA's quick approvals

February 14, 2015 2:03 AM UTC

FDA approved Lenvima lenvatinib ( E7080) from Eisai Co. Ltd. (Tokyo:4523) to treat progressive, radioiodine-refractory differentiated thyroid cancer. The approval comes well ahead of the drug's April 14 PDUFA date, making Lenvima at least the fifth cancer therapy in the past 10 months to be approved more than two months ahead of its PDUFA date.

The drug, which inhibits multiple VEGF receptor tyrosine kinases, was under Priority Review and has Orphan drug status. FDA based its approval on the Phase III SELECT trial, in which patients receiving Lenvima had median PFS of 18.3 months vs. 3.6 months with placebo. Eisai spokesperson Suzanne Grogan said the company expects to make the drug available through specialty pharmacies by the end of the month, at which time it will announce the drug's price. ...