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FDA Approval Sought for Lenvatinib in Differentiated Thyroid Cancer

Silas Inman @silasinman
Published: Sunday, Aug 31, 2014

Dr. Martin Schlumberger

Martin Schlumberger, MD

Eisai has submitted a New Drug Application for lenvatinib (E7080) as a treatment for patients with progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC), based on findings from the phase III SELECT trial that was presented at the 2014 ASCO Annual Meeting. The FDA will review the application by mid-October, at which point a decision timeline under the Prescription Drug User Fee Act will be established. The fastest review under this program provides a decision within 6 months.
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