FDA Waiting For EGFR Diagnostic Kit Data As Supplement To Vectibix BLA
In what could signal a trend for targeted therapies, FDA concluded in its review of Amgen's epidermal growth factor receptor inhibitor Vectibix that the diagnostic test kit used to screen subjects for EGFR expression would need to be submitted as a supplement to the BLA
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FDA review documents for Amgen's Vectibix (panitumumab) outline possible factors that may have lead to the epidermal growth factor receptor inhibitor's failure to show an overall survival benefit in a pivotal trial, including the possibility that the trial was not powered to show a modest effect
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