The U.S. Food and Drug Administration(FDA) today granted approval to lenvatinib (Lenvima) to treat patients with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine therapy. Lenvatinib is a tyrosine kinase inhibitor that binds to multiple sites involved in angiogenesis and proliferation.
“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. “Today’s approval gives patients and health-care professionals a new therapy to help slow the progression of differentiated thyroid cancer.”
Clinical Trial Details
Lenvatinib’s efficacy was demonstrated in a phase III trial of 392 participants with progressive, radioiodine-refractory differentiated thyroid cancer who were randomly assigned to receive either the study drug or a placebo. Study results showed lenvatinib-treated participants had a median progression-free survival of 18.3 months, compared with 3.6 months for participants who received a placebo. Additionally, 65% of participants treated with lenvatinib saw a reduction in tumor size, compared with the 2% of participants who received a placebo. A majority of participants randomly assigned to receive the placebo were treated with lenvatinib upon disease progression.
Adverse Events
The most common side effects of lenvatinib were hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia.
Lenvatinib may cause serious side effects, including cardiac failure, arterial thromboembolic events, hepatotoxicity, renal failure and impairment, gastrointestinal perforation or fistula formation, QT interval prolongation, hypocalcemia, reversible posterior leukoencephalopathy syndrome, hemorrhage, risks to an unborn child if a patient becomes pregnant during treatment, and impaired suppression of the production of thyroid-stimulating hormone.
Lenvatinib was reviewed under the FDA’s Priority Review program, which provides for an expedited review of drugs that, if approved, would provide significant improvement in safety or effectiveness in the treatment of a serious condition. The drug also received Orphan Product designation because it is intended to treat a rare disease. Lenvatinib is being approved approximately 2 months ahead of the prescription drug user fee goal date of April 14, 2015, the date when the Agency was scheduled to complete its review of the application.
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