Posted by Michael Wonder on 13 May 2019
Lilly's Cyramza (ramucirumab) becomes first FDA approved biomarker-driven therapy in patients with hepatocellular carcinoma
13 May 2019 - This new indication - the fifth FDA approval for Cyramza in an advanced or metastatic cancer - is for the second-line treatment of patients with hepatocellular carcinoma who are AFP-High (AFP ≥400 ng/mL).
Eli Lilly and Company today announced that the U.S. FDA has approved 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) of ≥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 labelling.
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.
