European regulators have agreed to undertake an accelerated assessment of Eisai’s lenvatinib as a treatment for progressive radioiodine-refractory, differentiated thyroid cancer.

The drug, which carries Orphan Status in the EU, is to be filed “imminently” and could become the first in a new class of tyrosine kinase inhibitors, the drugmaker said.

Thyroid cancer is the most common endocrine malignancy, with around 50,000 cases new cases diagnosed a year in Europe alone.

Treatments are available for most forms of the disease, but there remains an unmet need for options once the disease has progressed, Eisai stressed.

The drug’s submission is based on data from the Phase III SELECT trial which showed the drug was able to extend progression free survival (PFS) compared to placebo, with median PFS coming in t 18.3 months and 3.6 months, respectively.