FDA Approves Lenvima (lenvatinib) for RAI-refractory Progressive Differentiated Thyroid Cancer

February 13, 2015— The U.S. Food and Drug Administration today granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC, including papillary, follicular, and variants) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). 

Lenvima is a kinase inhibitor, which works by blocking certain proteins from helping cancer cells grow and divide. Lenvima is marketed by Eisai Inc. 

“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” said Richard Pazdur, M.D., 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 healthcare professionals a new therapy to help slow the progression of DTC.”  

Lenvima 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. Lenvima is being approved approximately two 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. 

Lenvima’s efficacy was demonstrated in 392 participants with progressive, radioactive iodine-refractory DTC who were randomly assigned to receive either Lenvima or a placebo.  Study results showed Lenvima-treated participants lived a median of 18.3 months without their disease progressing (progression-free survival), compared to a median of 3.6 months for participants who received a placebo. 

Additionally, 65 percent of participants treated with Lenvima saw a reduction in tumor size, compared to the two percent of participants who received a placebo. A majority of participants randomly assigned to receive the placebo were treated with Lenvima upon disease progression. 

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