Amgen panitumumab gets fast-track status
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Amgen's epidermal growth factor receptor inhibitor panitumumab gets fast-track designation for treatment of metastatic colorectal cancer patients who have failed standard chemotherapy, the company announces Aug. 1. Amgen plans to initiate the BLA "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." Prior to the fast-track designation, Amgen indicated it would submit panitumumab in the second half of 2005 (1Pharmaceutical Approvals Monthly April 2005, In Brief)...