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.
Eisai Co., Ltd. and Merck, known as MSD outside the United States and Canada, received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for Eisai’s multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib) in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC).
The Lenvima and Keytruda combination therapy is being jointly developed by Eisai and Merck. This is the second breakthrough therapy designation for Lenvima and the twelfth granted to Keytruda.
The breakthrough therapy designation is an FDA program intended to expedite development and review of drugs for serious or life-threatening conditions. In order to qualify for this designation, preliminary clinical evidence must demonstrate that the drug may provide substantial improvement over currently available therapy on at least one clinically significant endpoint.
The benefits of the designation include more intensive guidance on an efficient drug development program, access to a regulatory liaison to help accelerate review time, and eligibility for rolling review as well as priority review.
This breakthrough therapy designation was based on the results of the RCC cohort in Study 111, a multicenter, open-label phase 1b/2 clinical study being carried out in the U.S. and the European Union (EU) to evaluate the efficacy and safety of Lenvima in combination with Keytruda in subjects with selected solid tumors.
The combination of Lenvima and Keytruda is investigational. The efficacy and safety of this combination has not been established.
(Source: Eisai Inc.)
Filed Under: Drug Discovery