Policy & Regulation
USFDA approves Eli Lilly's CYRAMZA
15 May 2019 -

The United States Food and Drug Administration (USFDA) has approved US-based Eli Lilly's CYRAMZA for the treatment of hepatocellular carcinoma, it was reported yesterday.

This approval is based on the results from a REACH-2 study, the first positive Phase three HCC trial in a biomarker-selected patient population. REACH-2 was a global, randomised, double-blind, placebo-controlled Phase three study of CYRAMZA compared to placebo in patients with hepatocellular carcinoma who have been treated with sorafenib and are considered AFP-High.

Andrew X Zhu, MD, director of Liver Cancer Research at Massachusetts General Hospital Cancer Center, and the principal investigator of the REACH-2 trial, said, 'This approval of CYRAMZA is an important step forward in the treatment of advanced hepatocellular carcinoma. While there have been some recent advances, there are still limited treatment options for people with this type of cancer and – until now – there was no treatment option specifically indicated for patients with increased alpha-fetoprotein concentrations. These patients can have more aggressive disease and a poorer prognosis with increased angiogenesis.'