The FDA has approved lenvatinib (Lenvima, Eisai Inc.) for treatment of patients with progressive, differentiated thyroid cancer that is refractory to radioactive iodine therapy, according to a press release from the agency.
The drug was reviewed under the FDA’s priority review program and also received orphan product designation, as it is intended to treat a rare condition. Lenvima’s approval comes approximately 2 months ahead of the prescription drug user fee goal date of April 14, 2015, the date at which the FDA was scheduled to complete review of Lenvima’s application, according to the release.
The drug’s safety and efficacy was evaluated in a trial involving 392 participants with progressive, radioactive iodine-refractory differentiated thyroid cancer who were randomly assigned to receive Lenvima or placebo.
Data indicated that participants who received Lenvima lived a median of 18.3 months without disease progression vs. 3.6 months in those who received placebo.
Further, 65% of participants treated with Lenvima experienced a decrease in tumor size, as compared with 2% of those who received placebo.
Most participants in the placebo group received Lenvima upon disease progression.
“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 the release. “Today’s approval gives patients and health care professionals a new therapy to help slow the progression of [differentiated thyroid cancer].”
Hypertension, fatigue, diarrhea, arthralgia and myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, swelling and pain in the palms and/or the soles of feet, abdominal pain and changes in voice volume or quality were the most common side effects.
The release also states that Lenvima can cause serious side effects, including cardiac failure, arterial thromboembolic events, hepatotoxicity, renal failure or impairment, gastrointestinal perforation or fistula formation, QT interval prolongation, hypocalcemia, the simultaneous occurrence of headache, confusion, seizures and visual changes, hemorrhage, risks to an unborn child if a patient becomes pregnant during treatment and impairing suppression of the production of thyroid-stimulating hormone.