Ramucirumab (Cyramza)

An agent indicated for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma with disease progression on or after fluoropyrimidine or platinum containing chemotherapy.

A monoclonal antibody against VEGFR2.

Approved as second line treatment in combination with standard chemotherapy for metastatic colorectal cancer following progression on a first line bevacizumab contaning regimen.

Approved in combination with docetaxel for second line treatment of metastatic non-small cell lung cancer, including non-squamous and squamous histologies.

An anti-angiogenic therapy.

Trade name Cyramza.

In a multi-national, randomized placebo-controlled study enrolling 665 with previously treated advanced or metastatic, gastric or GEJ adenocarcinoma, in which patients received either paclitaxel plus placebo or paclitaxel plus ramucirumab: This trial was reported to demonstrate a survival advantage for the ramucirumab combination.

The most common adverse reactions are: hypertension, diarrhea, hyponatremia, intestinal obstruction, and anemia.

Other reported risks include: hemorrhage, arterial thrombotic events, infusion-related reactions, gastrointestinal perforation, impaired wound healing, clinical deterioration in patients with cirrhosis, and reversible posterior leukoencephalopathy.

The recommended ramucirumab dose and schedule is 8 mg/kg administered as a 60-minute intravenous infusion every 2 weeks.

Overall survival as a single agent in patients who have failed previous chemotherapy is 5.2 months compared to placebo of 3.8 months, a 37% % increase in median overall survival.

Can increase the risk of hemorrhage, including severe and sometimes fatal hemorrhagic events.

Incidence of severe bleeding 3.4%.

Associated with sometimes serious, and fatal, arterial thrombolic events including myocardial infarction, cardiac arrest, cerebrovascular accidents, and cerebral ischemia in about 1.7% of patients who receive the drug.

Increased incidence of severe hypertension occurs in about 8% percent of patients.

Associated with increased risk of gastrointestinal perforation in 0.7% of patients.

Associated with a reversible posterior leukoencephalopathy syndrome in 0.1% of patients.

Associated with improved overall survival when added to docetaxel in NSCLC.

The US Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) as a single agent treatment for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein of ≥400 ng/mL and have been previously treated with sorafenib.

Approval was based on REACH‑2, a multinational, randomised, double-blind, placebo-controlled, multicentre study.

Patients were randomised 2:1 to receive ramucirumab 8 mg/kg plus best supportive care or placebo plus best supportive care every 2 weeks as an intravenous infusion until disease progression or unacceptable toxicity.

The study found that the estimated median overall survival 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 were fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites.

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

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