The US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to lenvatinib plus pembrolizumab combination for the treatment of advanced and/or metastatic renal cell carcinoma (RCC), Eisai Co Ltd and Merck announced in a news release.

Lenvatinib, a multiple receptor tyrosine kinase inhibitor, and pembrolizumab, an anti-PD-1 therapy, have received 2 and 12 breakthrough therapy designations, respectively, prior to the most recent designation.

Breakthrough Therapy Designation was based on data from the ongoing phase 1b/2 Study 111 clinical trial, for which patients with select unresectable tumors received oral lenvatinib 20 mg daily plus intravenous pembrolizumab 200 mg once every 3 weeks.

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The most frequently reported adverse events (AEs) for lenvatinib in the treatment of RCC include hypertension, fatigue, diarrhea, arthralgia/myalgia; and for pembrolizumab, include fatigue, pruritis, diarrhea, decreased appetite, rash, dyspnea, constipation, and nausea.

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Lenvatinib is currently also indicated for differentiated thyroid cancer. Pembrolizumab is also indicated for the treatment of melanoma, lung cancer, non-small cell lung cancer, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancer, and gastric cancer.

FDA grants Breakthrough Therapy Designation to treatments that address a serious disease and provide early evidence of clinical benefit. Treatment must also lead to improvements on clinically significant end points over currently established therapies, and must also address significant unmet medical needs.


Eisai and Merck receive Breakthrough Therapy Designation from FDA for Lenvima® (lenvatinib mesylate) and Keytruda® (pembrolizumab) as combination therapy for advanced and/or metastatic renal cell carcinoma [news release]. Tokyo and Kenilworth, NJ: Eisai Co Ltd and Merck; January 9, 2018. Accessed January 9, 2018.