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.
Navigating Ethical, Financial Considerations When Delivering Cancer Care
April 30th 2024“I think in those situations where you can use the lower cost of the drug, you should, because it's going to help the overall societal perspective. That begins to break down, though, when that low-cost drug is the one that you're losing money on,” said Scott Soefje in a Q&A on balancing cost and margin at a site of care.