Amgen Drug Gets Fast Track

Biotechnology companies Amgen Inc. and Abgenix Inc. said Monday that U.S. regulators had granted colon cancer drug panitumumab fast-track status, bringing the treatment one step closer to U.S. approval.

Amgen and Abgenix are seeking approval for the drug for use in patients with advanced colorectal cancer who have failed standard chemotherapy treatment.

Panitumumab, an antibody-based cancer drug designed to block a protein that helps tumors grow, was shown in a mid-stage trial to reduce tumors in patients who previously failed to benefit from chemotherapy.

Fast-track status allows the Food and Drug Administration to accept portions of an application for review before the final filing is complete. It is intended for drugs aimed at treating life-threatening conditions with few treatment options.

Amgen and Abgenix said they expected to submit an application for approval by the end of 2005. The completed submission could extend into the first quarter of 2006, depending on timing and clinical data.

Thousand Oaks-based Amgen’s shares rose $1.86 to $81.63, and shares of Abgenix of Fremont, Calif., rose 33 cents to $10.70.