New thyroid cancer drug gets early approval13 Feb 2015
The United States FDA has given the green light to lenvatinib (trade name: Lenvima) for the treatment of a type of thyroid cancer called "radioiodine-refractory differentiated thyroid cancer".
The drug was approved two months ahead of its expected approval date, which was in April. It had been granted both orphan drug and priority review status. Lenvatinib is an oral drug, medically characterized as “an inhibitor of multiple kinase targets”.
Clinical results supporting the approval
A total of 392 patients with radioiodine-refractory differentiated thyroid cancer were randomized to either lenvatinib or to placebo. Median progression-free survival was 18.3 months with the drug, compared with 3.6 months for placebo.
The majority of patients assigned to placebo were treated with the drug upon disease progression, the FDA said. Results of the drug's pivotal phase 3 trial were published earlier this week in the New England Journal of Medicine.
FDA warning on the serious side-effects
The most common side effects included hypertension, fatigue, diarrhea, joint and muscle pain, diminished appetite, weight loss, nausea, stomatitis, headache, vomiting, proteinuria, swelling and pain in the palms and soles of the feet, abdominal pain, and dysphonia.
FDA warned that the drug may cause serious side effects including cardiac failure, thrombosis, liver damage, kidney damage, gastrointestinal perforation or fistula, QT interval prolongation, hypocalcemia, headache, confusion, seizures, visual changes, hemorrhage, fetal risks, and impaired suppression of thyroid-stimulating hormone release.
The only other drug approved for this type of thyroid cancer is sorafenib (Nexavar).
In the United States, Lenvatinib will be sold by Eisai's U.S. subsidiary in Woodcliff Lake, N.J.
Source: MedPage Today