The FDA granted breakthrough therapy designation to pembrolizumab in combination with lenvatinib as first-line treatment for patients with advanced unresectable hepatocellular carcinoma who are not able to receive locoregional treatment.

This is the third breakthrough therapy designation granted by FDA for pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — and lenvatinib (Lenvima, Eisai), a multiple receptor tyrosine kinase inhibitor.