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FDA Accepts Lenvatinib Application for Advanced HCC

Silas Inman @silasinman
Published: Tuesday, Sep 26, 2017

Kenichi Nomoto

Kenichi Nomoto, PhD
The FDA has accepted a supplemental new drug application for lenvatinib (Lenvima) as a frontline systemic treatment for patients with advanced hepatocellular carcinoma (HCC), according to a statement from the company developing the therapy, Eisai. Under a standard review, the FDA will render a decision within 10 months.

Lenvatinib is currently approved as a treatment for patients with recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer and following VEGF therapy in combination with everolimus for patients with advanced renal cell carcinoma.
Cheng A-L, Finn RS, Qin S, et al. Phase III trial of lenvatinib (LEN) vs sorafenib (SOR) in first-line treatment of patients (pts) with unresectable hepatocellular carcinoma (uHCC). J Clin Oncol. 2017;35 (suppl; abstr 4001).

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