EU approval for Eisai's Lenvima in thyroid cancer

The European Commission (EC) has issued marketing authorization for Japanese pharma major Eisai’s (TYO: 4523) Lenvima (lenvatinib) in the treatment of people with radioactive iodine refractory differentiated thyroid cancer.

The EC decision follows a recommendation for approval at the March 2015 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP; The Pharma Letter March 27). Lenvima has also been approved by the Food and drug Administration in the USA, where the drug saw its first launch in March, and regulators in Japan, where the drug debuted this month (TPL May 21). Eisai has previously said it believes this drug could generate sales of 30 billion yen ($252 million) by fiscal 2020.

Differentiated thyroid cancer accounts for 90% of all thyroid cancers and 5%15% of people with differentiated thyroid cancer will develop advanced thyroid cancer that is refractory to radioactive iodine. Lenvatinib is indicated for the treatment of adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI).