European regulators have issued clearance for Eisai’s Lenvima to treat the most common forms of thyroid cancer, following approvals in the US and Japan earlier this year.
The European Commission has ruled that the drug can be used to treat adult patients with progressive, locally advanced or metastatic differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Lenvima (lenvatinib) was reviewed in just nine months from filing under Europe’s accelerated assessment program, and also picked up Orphan designation in 2013.
Approval came on the back of clinical data showing patients given the drug lived on average 14.7 months longer without their disease progressing than those taking a placebo, and also experienced a rapid response with a median time to first objective response of 2.0 months.
Back in March the Committee for Medicinal Products for Human Use concluded that Lenvima has a safety profile consistent with other similar therapies with “predictable and manageable” side effects, but requested a further study to investigate the most appropriate starting dose to optimise the benefits and reduce risks.