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# FDA Approves Keytruda Plus Lenvima for Some Cancers
- URL: https://www.fdaweb.com/fda-approves-keytruda-plus-lenvima-for-some-cancers/
- Published: 2021-08-12T12:00:00.000Z
- Updated: 2026-09-14T17:10:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149923

FDA has approved Merck’s Keytruda (pembrolizumab) plus Eisai’s Lenvima (lenvatinib) for first-line treatment of adult patients with advanced renal cell carcinoma. Merck [says](https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-plus-lenvima-lenvatinib-combination-for-first-line-treatment-of-adult-patients-with-advanced-renal-cell-carcinoma-rcc/?ref=fdaweb.com) the approval was based on results from the pivotal Phase 3 CLEAR study in which the two drugs together demonstrated significant improvements versus sunitinib (Pfizer’s Sutent) in the efficacy outcome measures of progression-free survival, overall survival, and confirmed objective response rate.

The approval was reviewed under FDA’s real-time oncology review pilot program that intends to bring treatments to patients as soon as possible.

Keytruda plus Lenvima are now approved for two types of cancer, Merck says.