Medication Monitor

Generic Name (Trade Name—Company)
June 12, 2019


(Cyramza—Eli Lilly)
FDA approves ramucirumab for hepatocellular carcinoma

On May 10, 2019, FDA approved ramucirumab as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of 400 ng/mL or greater and have been previously treated with sorafenib.

Approval was based on REACH‑2, a multinational, randomized, double-blind, placebo-controlled, multicenter study in 292 patients with advanced HCC with AFP of 400 ng/mL or greater who had disease progression on or after sorafenib or who were intolerant.

The trial’s primary endpoint was overall survival (OS). The estimated median OS was 8.5 months for patients receiving ramucirumab and 7.3 months for those receiving placebo.

The most common adverse reactions observed in patients with HCC receiving single-agent ramucirumab (≥15% and ≥2% higher incidence than placebo) were fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites. The most common laboratory abnormalities (≥30% and a ≥2% higher incidence than placebo) were hypoalbuminemia, hyponatremia, and thrombocytopenia.

The recommended ramucirumab dosage is 8 mg/kg administered intravenously every 2 weeks.