Trials & Filings

Eisai’s Lenvatinib Gains Priority Review

For the potential treatment of unresectable advanced or metastatic renal cell carcinoma

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By: Kristin Brooks

Managing Editor, Contract Pharma

Eisai’s sNDA for lenvatinib has been accepted for Priority Review by the FDA for the potential treatment of unresectable advanced or metastatic renal cell carcinoma (RCC) in combination with everolimus following one prior vascular endothelial growth factor (VEGF)-targeted therapy. The FDA had previously granted lenvatinib Breakthrough Therapy designation for this indication.   Priority Review is intended for drugs that treat serious conditions and, if approved, would provide a significant impr...

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