FDA approves Cyramza for patients with hepatocellular carcinoma with an alpha-fetoprotein

Eli Lilly and Company announced that the FDA has approved Cyrazma (ramucirumab injection, 10 mg/mL solution), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of greater than 400 ng/mL and have been treated with sorafenib. Concurrent with this FDA approval – the fifth for Cyramza – the FDA has also removed the boxed warning from the Cyramza labeling..

HCC is the most common form of liver cancer, which is the fourth-leading cause of cancer-related death worldwide In the U.S., liver cancer is one of the few major cancers with incidence rates that continue to rise every year and is the fastest rising cause of cancer death. AFP is a prognostic biomarker that can be assessed through a simple blood test, now allowing physicians to select patients who may benefit from treatment and to monitor disease progression in advanced HCC.

This approval is based on the results from the REACH-2 study, the first positive Phase III HCC trial in a biomarker-selected patient population. REACH-2 is a global, randomized, double-blind, placebo-controlled Phase III study of Cyramza compared to placebo in patients with HCC who have been treated with sorafenib and are AFP-High (AFP greater than 400 ng/mL).