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The FDA has given the green light to lenvatinib (Lenvima), an inhibitor of multiple kinase targets, for the treatment of radioiodine-refractory differentiated thyroid cancer, .
The drug was approved months ahead of its PDUFA date in April. It had been granted both orphan drug and priority review status.
Results of the drug's pivotal phase III trial were published earlier this week in the New England Journal of Medicine.
A total of 392 patients with radioiodine-refractory differentiated thyroid cancer were randomized to either the kinase inhibitor 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, FDA said.
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.
Only one other drug is approved for this type of thyroid cancer: sorafenib (Nexavar).
Lenvatinib will be sold by Eisai's U.S. subsidiary in Woodcliff Lake, N.J.