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FDA Grants Priority Review to Ramucirumab as a Potential Single-Agent Treatment for Advanced Gastric Cancer

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Key Points

  • Ramucirumab is a human monoclonal antibody that specifically blocks the vascular endothelial growth factor receptor 2 and inhibits downstream signaling involved in angiogenesis.
  • If approved, ramucirumab would be the first FDA-approved therapy for patients with advanced gastric cancer.

The U.S. Food and Drug Administration (FDA) has assigned Priority Review to the regulatory submission for ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.

Ramucirumab is a human monoclonal antibody that specifically blocks the vascular endothelial growth factor receptor 2 and inhibits downstream signaling involved in angiogenesis.

The biologics license application for ramucirumab was based on data from REGARD, a global, randomized, double-blind phase III study of ramucirumab plus best supportive care vs placebo plus best supportive care as a treatment in patients with advanced gastric cancer (including adenocarcinomas of the gastroesophageal junction) following progression after initial chemotherapy.

“We are very pleased that the FDA has granted Priority Review to ramucirumab in advanced gastric cancer, as patients with this difficult-to-treat disease typically have a poor prognosis and limited treatment options,” said Richard Gaynor, MD, Vice President, Product Development and Medical Affairs for Lilly Oncology. “If approved, ramucirumab will be the first FDA-approved therapy for patients in this setting.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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