Eisai Co. Ltd., of Tokyo, and Merck & Co., of Kenilworth, N.J., received breakthrough therapy designation from the FDA for Eisai's multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib) in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of advanced or metastatic renal cell carcinoma. This is the second breakthrough therapy designation for Lenvima and the 12th for Keytruda.