This article is more than 5 years old. Information may no longer be current.
FDA approves Lenvima for progressive differentiated thyroid cancer
Click Here to Manage Email Alerts
The FDA today approved lenvatinib for patients with differentiated thyroid cancer whose disease progressed after receiving radioactive iodine therapy.
“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Today’s approval gives patients and health care professionals a new therapy to help slow the progression of [differentiated thyroid cancer.]”
Richard Pazdur
The approval of lenvatinib (Lenvima, Eisai) is based in part on results of a study that included 392 patients with differentiated thyroid cancer whose disease was refractory to radioactive iodine therapy. Researchers assigned patients to treatment with lenvatinib or placebo; however, a majority of patients in the placebo arm crossed over to treatment with lenvatinib at the time of disease progression.
Median PFS was 18.3 months in the lenvatinib arm vs. 3.6 months in the placebo arm. A greater proportion of patients assigned lenvatinib also experienced a reduction in tumor size (65% vs. 2%).
The most common adverse effects observed in patients who received lenvatinib were hypertension, fatigue, diarrhea, arthralgia, myalgia, decreased appetite and weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain and dysphonia.
Serious adverse effects associated with lenvatinib include cardiac failure, arterial thromboembolic events, hepatotoxicity, renal failure and impairment, gastrointestinal perforation, fistula formation, QT interval prolongation, hypocalcemia, reversible posterior leukoencephalopathy syndrome and hemorrhage.