Eisai has been boosted by news that regulators in the USA have agreed to a quicker review of its anticancer agent lenvatinib.
The US Food and Drug Administration has granted a priority review to Eisai’s New Drug Application for lenvatinib as a treatment for progressive radioiodine-refractory differentiated thyroid cancer. This means that the agency has assigned a Prescription Drug User Fee Act action date of April 14 next year, eight months after the NDA was submitted.
Lenvatinib has orphan drug designation for thyroid cancer in the USA, Japan and in Europe, where it has granted an accelerated assessment by the European Medicines Agency. The oral multiple receptor tyrosine kinase inhibitor is also being studied for hepatocellular carcinoma (Phase III), non-small cell lung cancer (Phase II) and other solid tumour types.
The FDA has also accepted for review a supplemental New Drug Application for its anti-epileptic Banzel (rufinamide) as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children aged one to three. The drug was approved for children aged four upwards in November 2008 and is marketed in Europe as Inovelon in Europe.
