Abgenix and Amgen Announce FDA Grants Panitumumab Fast Track Designation for Metastatic Colorectal Cancer
Monday August 1, 9:00 am ET
THOUSAND OAKS, Calif. & FREMONT, Calif.--(BUSINESS WIRE)--Aug. 1, 2005--Amgen (Nasdaq:AMGN - News) and Abgenix, Inc. (Nasdaq:ABGX - News) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for panitumumab, an experimental fully human monoclonal antibody directed against the epidermal growth factor receptor (EGFr), for patients with metastatic colorectal cancer who have failed standard chemotherapy treatment.
"We are advancing the development of panitumumab with the hope of offering patients a new treatment option in their fight against metastatic colorectal cancer," said Willard Dere, M.D., chief medical officer and senior vice president of global development at Amgen.
Under the FDA Modernization Act of 1997, fast track designation allows the FDA to accept, on a rolling basis, portions of a marketing application for review prior to the completion of the final registrational package. Fast track designation may potentially expedite the review of a drug that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition.
In light of this 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. The completed submission of the BLA could extend into the first quarter of 2006, depending on timing and outcome of clinical data. 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 United States.
"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, chief executive officer at Abgenix. "We are one step closer to bringing this promising new treatment to patients with advanced colorectal cancer."
Patients and physicians can access www.amgentrials.com for more information about ongoing panitumumab clinical trials... |
