FDA Approves Lenvima (lenvatinib) for Thyroid Cancer

The US Food and Drug Administration (FDA) has approved Lenvima (linvatinib) for a type of thyroid cancer. It’s for people with differentiated thyroid cancer that got worse even after they received radioactive iodine therapy. Lenvima is a type of targeted drug called a kinase inhibitor. It works by blocking tumors from forming new blood vessels, which the tumors need to grow. It also targets some of the proteins made by cancer cells that normally help them grow.

The FDA reviewed Lenvima under its priority review program, which is one way drugs can be approved faster if they show promise for treating a serious disease. The approval was based on a study of 392 people with differentiated thyroid cancer (such as papillary or follicular types) that grew after they received radioactive iodine therapy. People in the study who received Lenvima lived an average 18.3 months before their cancer started growing again compared to an average 3.6 months for people who did not receive Lenvima. In addition, 65% of people who received Lenvima had their tumors shrink compared with only 2% for people who did not receive Lenvima.

Lenvima is taken by mouth once a day. The most common side effects were high blood pressure, fatigue, diarrhea, joint and muscle pain, loss of appetite, weight loss, nausea, vomiting, swelling of the lining of the mouth, headache, excess protein in the urine, swelling and pain in the palms, hands and/or the soles of the feet, abdominal pain and voice changes.

Less common, but more serious side effects included heart failure, blood clots, liver damage, kidney damage, an opening in the wall of the stomach or intestines, changes in the heart’s electrical activity, low levels of calcium in the blood, serious bleeding, and risks to an unborn child if a patient becomes pregnant during treatment.

Lenvima is marketed by Eisai Inc.

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