Amgen preps panitumumab NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Amgen plans to submit its epidermal growth factor receptor inhibitor panitumumab in the second half of 2005 for treatment of third-line colorectal cancer, the firm says March 29. Two Phase III trials, one each in the U.S. and EU, are ongoing. "In recent discussions with the FDA, we have obtained favorable opinion regarding the acceptability of these studies for U.S. registration," Senior Director-Licensing Anthony Gringeri, PhD, tells investors at the Smith Barney Citigroup Healthcare conference. Amgen maintains the monoclonal antibody has advantages over Bristol-Myers Squibb/ImClone's EGFR agent Erbitux (cetuximab), including "fewer infusion reactions"...