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www.fdanews.com/articles/171539-ec-oks-eisais-lenvima-for-thyroid-cancer

EC OKs Eisai’s Lenvima for Thyroid Cancer

June 5, 2015

The European Commission last week approved Eisai’s Lenvima for thyroid cancer that is resistant to radioactive iodine therapy.

Lenvima (lenvatinib) is indicated for adults with progressive, locally advanced or metastatic differentiated thyroid cancer.

The decision was based on a study of 392 patients, which showed those given Lenvima lived a median of 18.3 months without disease progression, compared with 3.6 months for patients given a placebo. The trial also showed rapid response with Lenvima, with a median time of two months for first objective response, the Japanese drugmaker said. Complete response was seen in 1.5 percent of patients receiving Lenvima and none on placebo.

Lenvima was launched in the U.S. for this indication in February 2015. The drug is approved in Japan for the treatment of unresectable thyroid cancer. — Jonathon Shacat