FDA Okays Eisai's Lenvima For A Type Of Thyroid Cancer

(RTTNews) - The U.S. Food and Drug Administration granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). Lenvima is marketed by Woodcliff Lake, New Jersey-based Eisai Inc. (ESALY.PK).

The most common type of thyroid cancer, DTC is a cancerous growth of the thyroid gland which is located in the neck and helps regulate the body's metabolism. Lenvima is a kinase inhibitor, which works by blocking certain proteins from helping cancer cells grow and divide.

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.

The most common side effects of Lenvima were 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).

Lenvima may cause serious side effects, including cardiac failure, blood clot formation, liver damage, kidney damage, an opening in the wall of the stomach or intestines or an abnormal connection between two parts of the stomach or intestines , changes in the heart's electrical activity , low levels of calcium in the blood, the simultaneous occurrence of headache, confusion, seizures and visual changes , serious bleeding, risks to an unborn child if a patient becomes pregnant during treatment, and impairing suppression of the production of thyroid-stimulating hormone.