Ramucirumab Receives FDA Approval for Liver Cancer Treatment

On May 10, 2019, the United States Food and Drug Administration (FDA) approved treatment for patients with blood AFP (alpha-fetoprotein) > 400 ng/mL who had previously received sorafenib and were diagnosed with hepatocellular cancer (liver cancer), using ramucirumab (Cyramza) as a single agent.

Ramucirumab is a monoclonal antibody and a targeted agent in the antiangiogenic class. By inhibiting the VEGFR-2 protein, it prevents development of the blood vessels supplying the tumor.

Approval was based on a multinational, randomized, double-blind trial in 292 patients with advanced liver cancer, AFP ≥ 400 ng/mL and previous sorafenib treatment, with a placebo -controlled, multicenter design, called REACH‑2.

Patients were assigned to two arms in a 2-to-1 ratio. The experimental arm received ramucirumab 8 mg/kg every 2 weeks plus best supportive care, while the control arm received placebo plus best supportive care. Treatment continued until disease progression or unacceptable toxicity (side effects).

The trial’s primary endpoint was overall survival.

According to the REACH‑2 Study Results:

• Estimated median overall survival with ramucirumab plus best supportive care was 8.5 months , compared with placebo plus best supportive care, for which it was 7.3 months .
• Using ramucirumab instead of placebo reduced the risk of death by 29%.

The most common side effects in patients receiving single-agent ramucirumab for liver cancer were fatigue, peripheral edema (swelling in the hands and feet), hypertension, abdominal pain, reduced appetite, proteinuria (protein in the urine), nausea and ascites (fluid accumulation in the abdomen). The most common laboratory abnormalities were hypoalbuminemia, hyponatremia and thrombocytopenia.

The recommended ramucirumab (Cyramza) dose is 8 mg / kg given intravenously every 2 weeks. 

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Treatment options for advanced liver cancer are summarized below:

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Cyramza previously received FDA approval for gastric and non-small cell lung cancers in 2014 and colorectal cancer in 2015.