Eisai files for EU lenvatinib approval in renal cell carcinoma

Eisai has applied for European regulatory approval of its cancer therapy lenvatinib mesylate in a new indication.

A new application has been filed with the European Medicines Agency for lenvatinib for use in the treatment of advanced or metastatic renal cell carcinoma. As a new medicine that is expected to be of major public health interest, it has been granted accelerated review status.

Data from a phase II clinical study has shown that lenvatinib, when used on its own or in combination with everolimus, delivered a significant extension in progression-free survival compared to everolimus alone.

The company said: "Eisai is committed to exploring the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer and their families."

Lenvatinib is already sold in the US, Japan and Europe under the brand name Lenvima as a treatment for refractory thyroid cancer. It has also been granted breakthrough therapy designation for renal cell carcinoma in the US, with the manufacturer also planning to seek approval for the drug in this indication in Japan in the near future.