Following priority review, the US Food and Drug Administration (FDA) has approved Amgen Inc's panitumumab (Vectibix) for the treatment of advanced colon cancer. The drug is the first entirely human monoclonal antibody for the treatment of patients with epidermal growth factor receptor-expressing metastatic colorectal cancer after disease progression on or following fluoropyrimidine-, oxaliplatin(Drug information on oxaliplatin)-, and irinotecan(Drug information on irinotecan)-containing chemotherapy regimens.
Panitumumab received an accelerated approval after showing effectiveness in slowing tumor growth and, in some cases, reducing the size of the tumor, the FDA said in a statement. The approval was based on a progression-free survival endpoint. A pivotal trial also showed that patients treated with panitumumab showed a better-than-expected 46% decrease in the rate of tumor growth vs those who received supportive care.
As part of the approval, Amgen committed to conduct a postmarketing trial to show whether the drug improves patients' survival in patients with fewer prior chemotherapies, the FDA said.