In light of the fast track designation, Amgen and Abgenix are working toward initiating the submission of the Biologics License Application (BLA) for panitumumab in patients who have failed prior standard chemotherapy, including irinotecan and oxaliplatin, by the end of 2005 or in the first quarter of 2006.
The FDA has previously indicated that data from one pivotal trial, once completed, could be acceptable with additional data from other pending studies to support a submission for marketing approval in the US.
The drug is expected to provide competition for Erbitux, a similar antibody marketed by ImClone Systems.
“Panitumumab is the first fully human monoclonal antibody to inhibit EGFr, and fast track designation represents an important milestone in its development,” said Bill Ringo, CEO at Abgenix. “We are one step closer to bringing this promising new treatment to patients with advanced colorectal cancer.”