The FDA approved ramucirumab as single-agent therapy for certain patients with hepatocellular carcinoma.
The approval applies to use of ramucirumab (Cyramza, Eli Lilly) for patients who have an alpha fetoprotein of at least 400 ng/mL and have previously been treated with sorafenib (Nexavar, Bayer).
Ramucirumab — a fully human monoclonal antibody — previously received FDA approval for treatment of certain patients with advanced stomach or gastroesophageal cancer, metastatic non-small cell lung cancer or metastatic colorectal cancer.
The FDA based the new indication on results of the randomized, double-blind, placebo-controlled REACH-2 study, which included 292 patients with advanced HCC with alpha fetoprotein of at least 400 ng/mL. All patients experienced disease progression during or after sorafenib treatment or were intolerant to the drug.
Researchers randomly assigned patients 2:1 to best supportive care plus ramucirumab 8 mg/kg or placebo every 2 weeks via IV infusion. Treatment continued until disease progression or unacceptable toxicity.
OS served as the primary endpoint. Results showed longer median OS in the ramucirumab group (8.5 months vs. 7.3 months; HR = 0.71; 95% CI, 0.53-0.95).
The most common adverse reactions reported among patients with advanced HCC who received ramucirumab monotherapy included fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites. The most common laboratory abnormalities included hypoalbuminemia, hyponatremia and thrombocytopenia.