> ## Content Index > Fetch the complete content index at: https://www.fdaweb.com/llms.txt > Use this file to discover other available public pages before exploring further. # Eisai Files sNDA for Lenvima - URL: https://www.fdaweb.com/eisai-files-snda-for-lenvima/ - Published: 2017-07-25T12:00:00.000Z - Updated: 2026-09-14T22:36:20.000Z - Author: David McFarland - Tags: Drugs, #legacy-id-D5139219 Eisai has submitted a supplemental NDA for the first-line use of Lenvima (lenvatinib), a multiple receptor tyrosine kinase inhibitor for treating patients with hepatocellular carcinoma (HCC). The submission is based on positive results from the pivotal Phase 3 REFLECT trial. β€œIn this study, lenvatinib was the first systemic therapy to show non-inferior overall survival versus sorafenib in previously untreated patients with unresectable HCC and demonstrated statistically significant and clinically meaningful improvements in all three secondary efficacy endpoints β€” progression-free survival, time to progression and objective response rate,” the company says. Currently, Lenvima is indicated for treating differentiated thyroid cancer and renal cell cancer.