Eisai applies for regulatory approval of new thyroid cancer drug

Eisai has filed for EU and US regulatory approval of a promising new treatment for progressive radioiodine-refractory differentiated thyroid cancer.

The anticancer agent lenvatinib mesylate has already been granted orphan drug designation in the EU, US and Japan, while it has also been granted an accelerated assessment by the European Medicines Agency (EMA).

Featuring a novel mode of action, lenvatinib has demonstrated its safety and efficacy in a phase III trial called Select, which highlighted the drug's significant progression-free survival benefits when compared to placebo.

The EMA, along with the US Food and Drug Administration, will now assess the available evidence before coming to a final decision in the coming months.

Around 53,000 patients were newly diagnosed with thyroid cancer in Europe during 2012. Although treatment is possible for most forms of the disease, there are few available options once the condition has progressed past a certain point.

This comes after Eisai received European regulatory approval for a new indication for its breast cancer drug Halaven last month.