Posted by Michael Wonder on 23 Jul 2019
Merck and Eisai receive third breakthrough therapy designation from FDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination treatment
23 July 2019 - Designation granted for potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma not amenable to loco-regional treatment.
Merck and Eisai today announced that the U.S. FDA has granted breakthrough therapy designation for Keytruda, Merck’s anti-PD-1 therapy, in combination with Lenvima, the orally available kinase inhibitor discovered by Eisai, for the potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma not amenable to loco-regional treatment.
This is the third Breakthrough Therapy designation for the Keytruda plus Lenvima combination and is based on updated interim results from the Phase 1b trial KEYNOTE-524/Study 116. An earlier interim analysis was presented at the American Association for Cancer Research Annual Meeting 2019.
