FDA Approves Eisai’s Thyroid Cancer Drug Lenvima

The FDA approved Eisai’s Lenvima for thyroid cancer that has progressed despite radioactive iodine therapy.

Lenvima (lenvatinib) is one of a class of targeted anticancer drugs called kinase inhibitors that block specific proteins that allow cancer cells to grow and divide. While thyroid cancer tends to be slow-growing and easy to detect, some patients don’t respond to surgery or iodine radiation treatment, leaving them few treatment options, Eisai says.

The FDA granted Lenvima both orphan drug designation and priority review; ultimately approving the drug two months ahead of its scheduled review date.

Eisai tested the treatment in 392 patients with progressive thyroid cancer who did not see gains with iodine treatment and found that those given Lenvima lived a median of 18.3 months without disease progression, compared with 3.6 months for patients given a placebo.

A significant number of patients given Lenvima — 65 percent versus 2 percent of patients on placebo — also saw their tumors shrink. — Lena Freund