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Ramucirumab Approved as Single Agent For Hepatocellular Carcinoma
New indication joins a series of single-agent and combination treatments for various cancers.
The FDA has approved ramucirumab (CYRAMZA, Elli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) greater than 400 g/mL and have bene treated with sorafenib.
Approval is based upon a multinational, randomized, double-blind, placebo-controlled, multicenter study involving 292 patients with advanced HCC with AFP that either showed disease progression on or after treatment with sorafenib, or were intolerant to sorafenib.
The most common adverse reactions observed throughout the trial included fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites. Most common laboratory abnormalities included hypoalbuminemia, hyponatremia, and thrombocytopenia.
For HCC, the recommended dose is 8 mg/kg every 2 weeks.