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FDA Issues CRL To Merck, Eisai For Keytruda Plus Lenvima Combination - Quick Facts

Merck & Co, Inc. (MRK) and Eisai Co. Ltd. announced Wednesday that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding their applications seeking accelerated approval of Merck's Keytruda, plus Eisai's Lenvima, for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

Ahead of the Prescription Drug User Fee Act (PDUFA) action dates of Merck's and Eisai's applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival.

Consequently, the CRL stated that Merck's and Eisai's applications 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.

Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps.

The applications were based on data from the Phase 1b KEYNOTE-524/Study 116 trial, which showed clinically meaningful efficacy in the single-arm setting. A Breakthrough Therapy designation was granted by the FDA in July 2019.

Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, was initially approved by the FDA in 2014. Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered and developed by Eisai, was initially approved by the agency in 2015.

The Lenvima/Keytruda combination therapy is being jointly developed by Eisai and Merck as part of the strategic collaboration announced in March 2018.

Merck and Eisai are continuing to evaluate the Keytruda plus Lenvima combination across 13 different tumor types in 18 clinical trials, including the LEAP (LEnvatinib And Pembrolizumab) clinical program.

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