FDA Grants Fast Track Designation to Panitumumab for Metastatic Colorectal Cancer Treatment

THOUSAND OAKS, Calif. & FREMONT, Calif.—Amgen and Abgenix have announced a significant development in the fight against metastatic colorectal cancer. The U.S. Food and Drug Administration (FDA) has granted fast track designation to panitumumab, an experimental fully human monoclonal antibody targeting the epidermal growth factor receptor (EGFr). This designation is specifically for patients who have not responded to standard chemotherapy treatments.

Fast track designation is a process under the FDA Modernization Act of 1997 that allows for the rolling submission of a marketing application. This means that portions of the application can be reviewed before the final package is completed, potentially speeding up the review process for drugs that treat serious conditions and address unmet medical needs.

Amgen and Abgenix are preparing to submit a Biologics License Application (BLA) for panitumumab by the end of 2005, with the possibility of extending into the first quarter of 2006. The FDA has indicated that data from one pivotal trial, along with additional data from other studies, could support the submission for marketing approval in the United States.

Panitumumab represents a novel approach in cancer treatment as the first fully human monoclonal antibody to inhibit EGFr. It is being evaluated both as a monotherapy and in combination with other agents for treating various cancers, including colorectal, lung, and kidney cancers. The development of panitumumab is a collaborative effort between Amgen and Abgenix, utilizing Abgenix's XenoMouse(R) technology to create a fully human monoclonal antibody with a potentially favorable safety profile.

The epidermal growth factor receptor (EGFr) plays a crucial role in the growth of many cells, including cancer cells. Panitumumab works by binding to EGFr, preventing the binding of epidermal growth factor (EGF) and transforming growth factor alpha (TGFa), thereby interfering with the signals that stimulate cancer cell growth.

This development marks a significant milestone in the ongoing battle against metastatic colorectal cancer, offering hope for a new treatment option for patients who have exhausted standard chemotherapy options.