FDA approves supplement 35 for Eisai's Lenvima

The U.S. Food and Drug Administration approved supplement 35 to the new drug application for Lenvima, according to the agency's Drugs@FDA database. The submission status is listed as AP, with a status date of 2026-09-24.¹

Lenvima is sponsored by Eisai Inc. The product covers oral capsules of lenvatinib mesylate in two strengths, equivalent to 4 mg base and 10 mg base.¹

The FDA classified this submission as an efficacy supplement and assigned it standard review priority, according to the database record. The submission number is 35, and the application number is NDA206947.¹

Supporting documents tied to this approval were dated September 28, 2026, including an approval letter and an updated product label. The application documents list an approval letter and a label, both dated 20260928.¹

The record does not specify which indication or clinical data package prompted this particular efficacy supplement, nor does it detail changes to dosing, safety information, or labeling beyond confirming that a new label was issued alongside the approval letter. Readers seeking the specifics of what changed in the label should consult the linked FDA documents directly, as the database entry itself does not summarize the content of the update.

No additional details on trial results, indications, or regulatory rationale are included in this record beyond the administrative facts of submission type, sponsor, dosage forms, and approval date.