Treats locally recurrent or metastatic, progressive, radioactive … thyroid cancer (DTC). NDA 206947, held by Eisai Inc. Lenvatinib Mesylate.
As of Nov 13, 2026, NDA 206947 (Lenvima), held by Eisai Inc, was first approved by FDA on Feb 13, 2015, with 24 approved supplements and 0 published complete response letters.
LENVIMA is a kinase inhibitor that is indicated: Differentiated Thyroid Cancer For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). Renal Cell Carcinoma In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). In combination with belzutifan, for the treatment of adult patients with advanced renal cell carcinoma with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
| Sep 24, 2026 | Supplement 35Efficacy (new indication or use) · Standard review | Approved | |
| Jan 29, 2025 | Supplement 33Efficacy (new indication or use) · Priority review | Approved | |
| Jun 7, 2024 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Apr 3, 2024 | Supplement 30Efficacy (new indication or use) · Priority review | Approved | |
| Oct 23, 2023 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2021 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Aug 10, 2021 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Jul 21, 2021 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Sep 17, 2019 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Aug 15, 2018 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| May 13, 2016 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Feb 13, 2015 | Original applicationNew molecular entity · Priority review | Approved |
| LenvimaEQ 4MG BASE · capsule;oral | Lenvatinib Mesylate | RxReference drug |
| LenvimaEQ 10MG BASE · capsule;oral | Lenvatinib Mesylate | RxReference drug |
| Sep 24, 2026 | Supplement 35Efficacy (new indication or use) · Standard review | Approved | |
| Jan 29, 2025 | Supplement 33Efficacy (new indication or use) · Priority review | Approved | |
| Nov 20, 2024 | Supplement 32Labeling · Standard review | Approved | |
| Jun 7, 2024 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Apr 3, 2024 | Supplement 30Efficacy (new indication or use) · Priority review | Approved | |
| Oct 23, 2023 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Nov 10, 2022 | Supplement 24Labeling · Standard review | Approved | |
| Aug 5, 2022 | Supplement 25Labeling · Standard review | Approved | |
| Dec 19, 2021 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Aug 10, 2021 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Jul 21, 2021 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2020 | Supplement 18Labeling · Standard review | Approved | |
| Nov 10, 2020 | Supplement 16Labeling · Standard review | Approved | |
| Sep 14, 2020 | Supplement 17Labeling · Standard review | Approved | |
| Apr 23, 2020 | Supplement 13Labeling · Standard review | Approved | |
| Feb 20, 2020 | Supplement 12Labeling · Standard review | Approved | |
| Sep 17, 2019 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Dec 7, 2018 | Supplement 9Labeling · Standard review | Approved | |
| Aug 15, 2018 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jun 6, 2018 | Supplement 8Labeling · Standard review | Approved | |
| Jul 31, 2017 | Supplement 5Labeling · Standard review | Approved | |
| May 13, 2016 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Apr 22, 2016 | Supplement 4Labeling · Standard review | Approved | |
| Oct 16, 2015 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Feb 13, 2015 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
