Ramucirumab to treat hepatocellular carcinomaJuly 5, 2019
Eli Lilly said the US FDA has approved ramucirumab injection, 10 mg/mL solution (Cyramza), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of =400 ng/mL and have been treated with sorafenib.
This is the fifth approval for the drug by the FDA.
This approval is based on the results from the REACH-2 study, the first positive phase 3 HCC trial in a biomarker-selected patient population. REACH-2 is a global, randomized, double-blind, placebo-controlled Phase 3 study of ramucirumab compared to placebo in patients with HCC who have been treated with sorafenib and are AFP-High (AFP =400 ng/mL).
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.
The FDA has removed the boxed warning from the drug labelling which highlighted warnings pertaining to haemorrhage, gastrointestinal perforation and impaired wound healing. The updated ramucirumab labelling continues to provide important information on these specific risks, as well as other adverse events, Eli Lilly said.