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# FDA OKs Eisai NDA for Lenvima Use in Kidney Cancer
- URL: https://www.fdaweb.com/fda-oks-eisai-nda-for-lenvima-use-in-kidney-cancer/
- Published: 2016-05-16T12:00:00.000Z
- Updated: 2026-09-14T21:02:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135680

FDA has approved an Eisai NDA for Lenvima (lenvatinib) capsules for combination use with everolimus for treating advanced renal cell carcinoma following one prior anti-angiogenic therapy. Lenvatinib was first approved in 2015 for treating locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

The expanded approval was based on a randomized, multicenter study in patients with advanced or metastatic renal cell carcinoma who previously received anti-angiogenic therapy. The major efficacy outcome measure was investigator-assessed progression-free survival, which was 14.6 months for the lenvatinib plus everolimus arm versus 5.5 months for patients on the everolimus arm, according to an agency news [release](http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm501070.htm?ref=fdaweb.com).

Additionally, FDA says lenvatinib plus everolimus demonstrated numerically superior progression-free survival, an objective response rate, and overall survival, compared to lenvatinib monotherapy. The most common adverse reactions (greater than 30%) with lenvatinib in combination with everolimus were diarrhea, fatigue, arthralgia/myalgia, decreased appetite, vomiting, nausea, stomatitis/oral inflammation, hypertension, peripheral edema, cough, abdominal pain, dyspnea, rash, decreased weight, bleeding events, and proteinuria, it says.