The European Medicines Agency (EMA) is recommending that Lenvima (lenvatinib) be available across Europe for the treatment of some patients with thyroid cancer, following a fast-track assessment.
The medicines safety regulator is proposing that the product be marketed for patients with differentiated thyroid carcinoma (DTC) whose cancer has progressed despite receiving radioactive iodine treatment.
The EMA considered the marketing application via its accelerated assessment programme because the cancer is rare, patients have few treatment options and the prognosis can be poor as the disease is often undetected until an advanced stage.
Lenvatinib is a tyrosine kinase inhibitor. The drug works by blocking these enzymes, which can be found on the surface of cancer cells and are involved in the growth and spread of thyroid carcinoma.
The EMA recommendation follows the results of a phase III trial involving 392 patients with progressive DTC who no longer responded to radioactive iodine. The patients were given either lenvatinib or placebo. Patients treated with the drug lived on average 14.7 months longer without their disease progressing than patients treated with placebo.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) decided that lenvatinib’s safety profile was consistent with other similar therapies and that side effects were predictable and manageable. But it has requested a further study to investigate the most appropriate starting dose of lenvatinib in order to reduce risks for patients.
The CHMP recommendation now goes to the European Commission for final approval.
Lenvatinib was approved by the US Food and Drug Administration in February 2015.