FDA approves Lenvima for progressive, differentiated thyroid cancer
Lenvima is a kinase inhibitor that blocks certain proteins from helping cancer cells grow and divide. The efficacy of the drug was proven in 392 patients with progressive, radioactive-iodine-refractory. The study showed that patients treated with Lenvima lived a median of 18.3 months without disease progression. In comparison, patients given the placebo lived a median of 3.6 months without disease progression. Sixty-five percent of Lenvima patients had reduced tumor size in comparison to two percent of placebo patients.
“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research said. “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 and approved approximately two months ahead of the prescription drug user fee goal date of April 14, 2015.