The U.S. Food and Drug Administration (FDA) has granted approval to Lenvima (lenvatinib), which will be used to treat patients with progressive, differentiated thyroid cancer (DTC) who are not responding to radioactive iodine therapy (radioactive iodine refractory disease).
DTC is the most common type of thyroid cancer, and 1,890 people died from the disease in 2014. This new kinase inhibitor fights the cancer by blocking certain proteins that help it grow and divide.
"The development of new therapies to assist patients with refractory disease is of high importance to the FDA," said Richard Pazdur, 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."
A trial for the drug involved 392 participants with progressive, radioactive iodine-refractory DTC who were randomly assigned to receive either Lenvima or a placebo. The results revealed Lenvima-treated participants lived a median of 18.3 months without the disease progressing, compared to a median of 3.6 months for participants who took the placebo. The findings also showed 65 percent of patients treated with Lenvima exhibited a reduction in tumor size, compared to only 2 percent who received the placebo.
Common side effects of the drug included "high blood pressure (hypertension), fatigue, diarrhea, joint and muscle pain (arthralgia/myalgia), decreased appetite, decreased weight, nausea, inflammation of the lining of the mouth (stomatitis), headache, vomiting, excess protein in the urine (proteinuria), swelling and pain in the palms, hands and/or the soles of the feet (palmar-plantar erythrodysesthesia syndrome), abdominal pain and changes in voice volume or quality (dysphonia)," the FDA reported.
Serious potential side effects include "cardiac failure, blood clot formation (arterial thromboembolic events), liver damage (hepatotoxicity), kidney damage (renal failure and impairment), an opening in the wall of the stomach or intestines (gastrointestinal perforation) or an abnormal connection between two parts of the stomach or intestines (fistula formation), changes in the heart's electrical activity (QT Interval Prolongation), low levels of calcium in the blood (hypocalcemia), the simultaneous occurrence of headache, confusion, seizures and visual changes (Reversible Posterior Leukoencephalopathy Syndrome), serious bleeding (hemorrhage), risks to an unborn child if a patient becomes pregnant during treatment, and impairing suppression of the production of thyroid-stimulating hormone," according to the FDA.
