Cyramza (ramucirumab)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved May 2019

Specific Treatments:

hepatocellular carcinoma with elevated alpha-fetoprotein (AFP)

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General Information

Cyramza (ramucirumab) is a human VEGFR2 antagonist and it is a recombinant human IgG1 monoclonal antibody.

Cyramza is specifically indicated as a single agent for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.

Cyramza is supplied as an injection for intravenous administration. The recommended dosage of Cyramza is 8mg/kg every 2 weeks administered by intravenous infusion over 60 minutes. Continue Cyramza until disease progression or unacceptable toxicity.

Clinical Results

FDA Approval

The FDA approval of Cyramza for hepatocellular carcinoma was based on results from the REACH-2 study, a Phase 3 HCC trial in a biomarker-selected patient population. REACH-2 was a global, randomized, double-blind, placebo-controlled study evaluating Cyramza versus placebo in patients with HCC who have been treated with sorafenib and are AFP-High (AFP ≥400 ng/mL). Cyramza showed a statistically significant benefit in the primary endpoint of overall survival (OS) and in the secondary endpoint of progression-free survival (PFS). Results showed that treatment with Cyramza significantly improved the OS of patients compared to placebo. Median OS was 8.5 months with Cyramza compared to 7.3 months with placebo. For the secondary endpoints, median PFS was improved with Cyramza to 2.8 months compared to 1.6 months for placebo. Objective response rate was numerically higher with Cyramza compared to placebo, 4.6 percent vs. 1.1 percent. In addition, disease control was higher with Cyramza than placebo, 59.9 percent compared to 38.9 percent.

Side Effects

Adverse effects associated with the use of Cyramza for hepatocellular carcinoma may include, but are not limited to, the following:

fatigue

peripheral edema

hypertension

abdominal pain

decreased appetite

proteinuria

nausea

ascites

Laboratory abnormalities, including thrombocytopenia, hypoalbuminemia, and hyponatremia

Mechanism of Action

Cyramza (ramucirumab) is a human VEGFR2 antagonist and it is a recombinant human IgG1 monoclonal antibody. Cyramza specifically binds VEGFR2 and blocks binding of VEGFR ligands, VEGF-A, VEGF-C, and VEGF-D. As a result, ramucirumab inhibits ligand-stimulated activation of VEGFR2, thereby inhibiting ligand-induced proliferation, and migration of human endothelial cells.

Additional Information

For additional information regarding CYramza or hepatocellular carcinoma, please visit https://www.cyramza.com