FDAnews
www.fdanews.com/articles/85748-amgen-reports-colorectal-cancer-study-results

AMGEN REPORTS COLORECTAL CANCER STUDY RESULTS

April 3, 2006

Amgen has reported pivotal Phase III results demonstrating that panitumumab significantly improved progression-free survival and disease control (response rate and stable disease) compared to best supportive care (BSC) in metastatic colorectal cancer patients who had failed standard chemotherapy.

In this multinational, open-label study, 463 patients with metastatic colorectal cancer who had failed standard chemotherapy, including oxaliplatin and irinotecan, were randomized to receive 6 mg/kg panitumumab plus BSC every two weeks or BSC alone. An independent, central radiology review board assessed disease progression and tumor shrinkage.