Upon invitation from the U.S. Food and Drug Administration (FDA), Amgen, along with four other sponsor companies, will meet with the FDA and its Oncologic Drugs Advisory Committee (ODAC) on February 8, 2011 for a discussion on the status of Subpart E or H (accelerated approval) Phase 4 post-marketing commitments for six oncology indications, including Vectibix® (panitumumab) which is indicated as a single agent for the treatment of chemorefractory metastatic colorectal cancer (mCRC).

The FDA has also asked the sponsors to participate in an open discussion with the committee on the accelerated approval process. Amgen looks forward to the discussion at the ODAC and to further collaboration with the agency on this process.

Click here to view Amgen’s briefing document for the meeting.