FDA Grants Breakthrough Designation to Frontline Pembrolizumab/Lenvatinib for HCC

July 23, 2019 – The FDA has granted a breakthrough therapy designation to the combination of pembrolizumab and lenvatinib for the first-line treatment of patients with advanced unresectable hepatocellular carcinoma (HCC) that is not amenable to locoregional therapy. The designation is based on updated interim findings from the phase Ib KEYNOTE-524/Study 116 trial. Earlier interim data, which were presented at the 2019 AACR Annual Meeting, showed that the combination … (leggi tutto)