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# Merck, Eisai Get ‘Complete Response’ on Combo Therapy
- URL: https://www.fdaweb.com/merck-eisai-get-complete-response-on-combo-therapy/
- Published: 2020-07-08T12:00:00.000Z
- Updated: 2026-09-14T16:20:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147153

FDA has issued Merck and Eisai a complete response letter on their request for accelerated approval of an NDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). The agency told the companies that another combination therapy (presumably Roche’s Avastin and Tecentriq) was recently approved based on a randomized, controlled trial that demonstrated overall survival in the same indication, the companies say. Consequently, the letter said that Merck’s and Eisai’s combination therapies “do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease,” according to the companies.

Merck and Eisai say that since their combination no longer meets the criteria for accelerated approval, they plan to work with FDA to gain traditional approval, which includes conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.  
“As such, LEAP-002, the Phase 3 trial evaluating the Keytruda plus Lenvima combination as a first-line treatment for advanced HCC, is currently underway and fully enrolled,” they say.