The U.S. Food and Drug Administration (FDA) has invited Amgen, along with other sponsor companies, to participate in a February 8, 2011 meeting of the Oncologic Drugs Advisory Committee (ODAC) for a discussion on the status of Subpart E or H (accelerated approval) Phase 4 post-marketing commitments for six oncology indications, including the use of Vectibix® (panitumumab) as a monotherapy treatment in metastatic colorectal cancer (mCRC).

In addition to providing updates on the status of their respective post-marketing studies, the FDA has asked the sponsors to participate in an open discussion with the committee on the accelerated approval process.

Amgen has completed and submitted the main post-marketing commitment relating to the confirmatory trial, Study 20050181 (the ‘181’ study), for Vectibix and in October and November 2010 submitted Supplemental Biologics License Applications (sBLA) to the FDA for first- and second-line use of Vectibix in combination with chemotherapy in patients with wild-type KRAS mCRC. Participation in this meeting is not part of FDA review of these pending sBLA applications.