FDA approves Lenvima for a type of thyroid cancer

FDA has approved lenvatinib (Lenvima, Eisai) for the treatment of progressive, differentiated thyroid cancer.

Differentiated thyroid cancer (DTC) is the most common type of thyroid cancer and is characterized by a cancerous growth of the thyroid gland, which is located in the neck and helps regulates the body’s metabolism. The National Cancer Institute estimates that more than 62,000 Americans were diagnosed and approximately 1,890 died from DTC in 2014.

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Lenvima is a receptor tyrosine kinase (RTK) inhibitor that acts by inhibiting the kinase activities of vascular endothelial growth factor (VEGF) receptors. The drug’s action inhibits RTKs involved in the tumor growth and progression of DTC. Lenvima is approved to treat patients with DTC whose disease progressed despite receiving radioactive iodine therapy.

"The incidence of thyroid cancer has been increasing globally over the last 50 years and for patients with thyroid cancer that progresses following surgery and radioactive iodine treatment, the prognosis is often poor," said Gary Bloom, executive director of ThyCa: Thyroid Cancer Survivors' Association, Inc. "We are excited about the approval of Lenvima, which may help address an unmet need as there are limited treatment options for patients with this type of thyroid cancer."

Lenvima was approved following a priority review by FDA. The drug also received orphan product designation.

Lenvima’s efficacy was demonstrated in a clinical trial which included 392 participants with progressive, radioactive iodine-refractory DTC who were randomly assigned to receive either Lenvima or a placebo. Patients treated with Lenvima had a progression-free survival of 18.3 months compared to 3.6 months for those who received placebo. Those treated with Lenvima also saw a 65% reduction in tumor size compared to 2% for the placebo-treated group.

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The most common side effects associated with the use of Lenvima included hypertension, fatigue, diarrhea, joint and muscle pain, decreased appetite, headache, proteinuria, and abdominal pain. Lenvima may also cause more serious side effects such as cardiac failure, blood clot formation, liver and kidney damage, gastrointestinal perforation, and QT interval prolongation. Lenvima can also cause fetal harm if administered to a pregnant woman.  Health care professionals should know that when treating with Lenvima, management of some adverse reactions may require dosing adjustments as needed.

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.