9 January 2018 - Eisai and Merck announced today that they received breakthrough therapy designation from the U.S. FDA for Eisai’s multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate) 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. 

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 breakthrough therapy designation granted to Keytruda.

This breakthrough therapy designation was based on the results of the renal cell carcinoma cohort in Study 111,1 a multicenter, open-label Phase Ib/II clinical study being carried out in the United States and the European Union to evaluate the efficacy and safety of Lenvima in combination with Keytruda in subjects with selected solid tumours.

Read Eisai press release