CHMP backs Eisai's Lenvima

EMA's CHMP recommended marketing authorization for Lenvima lenvatinib from Eisai Co. Ltd. (Tokyo:4523) to treat adults with progressive, radioiodine-refractory, locally advanced or metastatic differentiated thyroid carcinoma. EMA reviewed Lenvima under its accelerated assessment program; it has Orphan Drug designation in the EU and the U.S.

FDA approved the inhibitor of multiple VEGF receptor tyrosine kinases in February. SFJ Pharmaceuticals Inc. (Pleasanton, Calif.), which funded Phase III trials of Lenvima in thyroid cancer, was eligible for a milestone payment upon its U.S. approval. Eisai declined to disclose whether SFJ is eligible for a payment upon Lenvima's European approval (see BioCentury Extra, Feb. 13). ...