To treat differentiated thyroid cancer that has progressed despite radioactive iodine therapy
FRIDAY, Feb. 13, 2015 (HealthDay News) — The kinase inhibitor Lenvima (lenvatinib) has been approved by the U.S. Food and Drug Administration to treat differentiated thyroid cancer that has progressed despite radioactive iodine therapy, the agency said Friday in a news release.
Lenvima was clinically evaluated among 392 people with differentiated thyroid cancer. Those given the new drug lived an average of 18.3 months without cancer progression, compared with 3.6 months among people given a placebo.
Lenvima’s most common side effects included hypertension, fatigue, diarrhea, arthralgia/myalgia, loss of appetite, nausea, stomatitis, headache, vomiting, and proteinuria. More serious side effects included heart failure, arterial thromboembolic events, hepatotoxicity, renal failure and impairment, and risks to the unborn child if a female user became pregnant.
“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s approval gives patients and health care professionals a new therapy to help slow the progression of differentiated thyroid cancer.”
Lenvima is marketed by Eisai Inc., based in Woodcliff Lake, N.J.