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# FDA Accepts Eisai sNDA for Liver Cancer Therapy
- URL: https://www.fdaweb.com/fda-accepts-eisai-snda-for-liver-cancer-therapy/
- Published: 2017-09-26T12:00:00.000Z
- Updated: 2026-09-14T22:52:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139718

FDA has accepted for review an Eisai supplemental NDA for Lenvima (lenvatinib) for use in first-line treatment of patients with hepatocellular carcinoma (liver cancer). The submission is based on data from the pivotal Phase 3 REFLECT trial. In the study, lenvatinib reportedly demonstrated a treatment effect on overall survival by statistical confirmation of non-inferiority to sorafenib. “This is the first positive Phase 3 study of a systemic treatment in comparison to sorafenib in this patient population,” the company says. “Additionally, patients experienced statistically significant and clinically meaningful improvements in the secondary efficacy endpoints of progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR).” Lenvima is currently FDA approved for treating thyroid and kidney cancer.