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FDA Approves Ramucirumab for Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Ramucirumab is intended for patients with unresectable or metastatic disease after treatment with a fluoropyrimidine- or platinum-containing therapy
23 Apr 2014
Gastrointestinal cancers

The US Food and Drug Administration (FDA) approved on 21 April, 2014 ramucirumab (Cyramza) to treat patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma. It is a fully human monoclonal antibody of the IgG1 class, directed against the vascular endothelial growth factor receptor 2 (VEGFR2).  Ramucirumab is intended for patients with unresectable or metastatic disease after treatment with a fluoropyrimidine- or platinum-containing therapy.

“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” said Dr Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Ramucirumab reviewed under FDA priority review program

Ramucirumab’s safety and effectiveness were evaluated in a clinical trial of 355 participants with unresectable or metastatic gastric or gastroesophageal junction cancer. Two-thirds of trial participants received ramucirumab while the remaining participants received a placebo. The trial was designed to measure overall survival.

The results showed that participants treated with ramucirumab experienced a median overall survival of 5.2 months compared to 3.8 months in participants receiving placebo. Additionally, participants who were treated with ramucirumab experienced a delay in tumour growth (progression-free survival) compared to participants who were given placebo.

The results from a second clinical trial that evaluated the efficacy of ramucirumab plus paclitaxel versus paclitaxel alone also showed an improvement in overall survival.

Common side effects experienced by ramucirumab-treated participants during clinical testing include diarrhoea and hypertension.

The FDA reviewed ramucirumab under its priority review program, which provides an expedited review for drugs that have the potential, at the time the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition.

Ramucirumab was also granted orphan product designation because it is intended to treat a rare disease or condition.

It is marketed by Eli Lilly.

Last update: 23 Apr 2014

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