Breaking News, Trials & Filings

Amgen’s Panitumumab Gets Priority Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Amgen’s BLA for panitumumab, an investigational fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr), has been granted Priority Review by the FDA. The BLA was submitted for the treatment of metastatic colorectal cancer patients who have failed prior chemotherapy, including oxaliplatin and/or irinotecan containing regimens. A Priority Review designation means that the FDA will target an Agency action within six months of the application’s submission...

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