Eli Lilly and Co. received approval from the U.S. FDA for CYRAMZA (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) 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. AFP is a prognostic biomarker that can be assessed through a blood test, 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. 

“This new indication for CYRAMZA further reinforces Lilly’s ongoing commitment to delivering meaningful medicines that are tailored for people with advanced cancers and the physicians that work in partnership with them,” said Anne White, president of Lilly Oncology. “Our work is focused on helping people who are living with cancer and Lilly is making strides in its efforts to develop precision medicine-based therapies for patients, to give them a fighting chance against their disease.”

The FDA has removed the boxed warning from the CYRAMZA labeling which highlighted warnings pertaining to hemorrhage, gastrointestinal perforation and impaired wound healing.