FDA Approves Second-Line Ramucirumab in AFP-Elevated HCC

May 10, 2019 – The FDA has approved ramucirumab monotherapy for patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of ≥400 ng/ML and have been previously treated with sorafenib). The approval was based on findings from the international, double-blind, placebo-controlled, multicenter phase III REACH-2 trial, in which the median overall survival (OS) was 8.5 months with ramucirumab compared with 7.3 months with placebo … (leggi tutto)