Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

Japanese pharma major Eisai (TYO: 4523) has filed applications with the US Food and Drug Administration and the European Medicines Agency for the use of lenvatinib mesylate in the treatment of patients with progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC).

This is seen as a further push into the oncology arena, following the loss of patent protection for its Alzheimer’s drug Aricept (donepezil), as well as loss of US exclusivity for gastrointestinal drug AcipHex (rabeprazole). Lenvatinib will add to Eisai’s already marketed breast cancer drug Halaven (eribulin).

An  application seeking marketing approval of lenvatinib for the indication of thyroid cancer was recently submitted in Japan. Lenvatinib was granted Orphan Drug Designation for thyroid cancer in Japan, Europe and the USA. Lenvatinib was also granted an accelerated assessment in Europe by the EMA, as it is a new medicine expected to be of major public health interest, particularly from the viewpoint of therapeutic innovation.