The US Food and Drug Administration (FDA) has approved lenvatinib (Lenvima) for the treatment of patients with progressive, differentiated thyroid cancer refractory to radioactive iodine. Differentiated thyroid cancer is the most common type of thyroid cancer.
“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “Today’s approval gives patients and healthcare professionals a new therapy to help slow the progression of differentiated thyroid cancer.”
The trial that led to lenvatinib’s approval showed that patients treated with the drug had an improved progression-free survival over those treated with placebo.
The multicenter trial (E7080-G00-303) enrolled 392 patients with locally recurrent or metastatic differentiated thyroid cancer refractory to radioactive iodine. Patient’s were randomized (2:1) to either lenvatinib 24 mg (n = 261) or placebo (n = 131).
Results of the trial showed that patients treated with lenvatinib had a progression-free survival of 18.3 months compared with 3.6 months for patients treated with placebo (hazard ratio = 0.21; 95% CI: 0.16–0.28; P < .001). Lenvatinib also improved objective response rates over placebo (65% vs 2%).
Patients receiving placebo were allowed to crossover to the lenvatinib arm after evidence of disease progression (83% of patients).
Sixty-eight percent of patients receiving lenvatinib had adverse events (AEs) that led to dose reductions. Eighteen percent of patients had to discontinue the drug due to toxicities.
The most common AEs among patients treated with lenvatinib were fatigue, nausea, arthralgia/myalgia, diarrhea, vomiting, proteinuria, decreased appetite and weight, palmar-plantar erythrodysesthesia syndrome, stomatitis, headache, dysphonia, and abdominal pain.
The most common serious AEs were pneumonia (4%), dehydration (3%), and hypertension (3%).