Tarceva’s Paucity Of EGFR Status Data Reflects “Emerging Problem” – FDA Review
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
A possible lack of survival benefit for Tarceva in epidermal growth factor receptor-negative patients led FDA to require postmarketing studies addressing receptor status, despite OSI’s insistence that EGFR status is “not important,” review documents state.
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