Amgen Panitumumab Could See Third Quarter Approval For Third-Line Colorectal Cancer
This article was originally published in The Pink Sheet Daily
Executive Summary
Amgen and development partner Abgenix are seeking priority review for the epidermal growth factor inhibitor.
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Amgen/Abgenix' panitumumab could have a late September user fee date for third-line metastatic colorectal cancer if FDA grants the BLA priority review. The companies announced March 30 that they have completed submission of panitumumab; the rolling BLA for the epidermal growth factor inhibitor was initiated in December. The application is supported by data from a 463-patent study that found patients who received panitumumab showed 46% less tumor growth than those who received "best supportive care" alone (1 (Also see "Panitumumab Pivotal Study Shows Increase In Progression-Free Survival" - Pink Sheet, 3 Nov, 2005.)). The panitumumab data will be presented April 3 at the American Association for Cancer Research meeting in Washington, D.C. Further development of panitumumab is slated to ramp up in the second half of 2006, with studies planned to evaluate treatment of first-line locally advanced and recurrent or metastatic squamous cell head and neck cancer and first- and second-line colorectal cancer, the companies said. Amgen's bid to acquire Abgenix is moving forward; Abgenix announced March 29 that shareholders have approved the transaction and the merger is on target to close April 1. The $2.2 bil. deal was inked in December (2 (Also see "Amgen’s Busy Week: Firm Acquires Panitumumab Partner Abgenix, Starts BLA" - Pink Sheet, 19 Dec, 2005.)). -Todd Leeuwenburgh |