Amgen's panitumumab has an estimated mid-September user fee date under FDA priority review for metastatic colorectal cancer patients failing prior chemotherapy, the company announced June 12.

Amgen initiated the rolling BLA submission for the IgG2 monoclonal antibody in December and completed the filing in March. Panitumumab targets the epidermal growth factor receptor.

The company presented partial data from two Phase II trials June 3 at the American Society of Clinical Oncology annual meeting in Atlanta. Data showed a partial response for patients with either low or negative levels of tumor EGFr staining in 13% of subjects (3/23) and stable disease in 30% of subjects (7/23).

In metastatic colorectal cancer patients with tumor levels of at least 10%, the antibody showed partial response in 8% of patients (3/39) and 30% showed stable disease (19/39), the company said.

Amgen submitted marketing applications for panitumumab to the European Medicines Agency and Health Canada in April, with filings in Australia and Switzerland in May. Amgen acquired the antibody when it purchased former development partner Abgenix (¹ Also see "Amgen Panitumumab Could See Third Quarter Approval For Third-Line Colorectal Cancer" - Pink Sheet, 30 March, 2006.).

Amgen Gets Panitumumab Priority Review

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