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Amgen panitumumab BLA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Amgen and Abgenix complete a rolling BLA submission for the epidermal growth factor inhibitor panitumumab to treat third-line metastatic colorectal cancer, the firms announce March 30. If granted a requested priority review, Amgen could see approval by September. Amgen presented data from the 463-patient pivotal trial supporting the BLA at the April 3 American Association for Cancer Research meeting in Washington, D.C. Amgen completed its $2.2. bil. acquisition of Abgenix on March 30; the deal was first announced in December (1Pharmaceutical Approvals Monthly January 2005, p. 42)...

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