Perjeta’s Data, Not Regimen, Get FDA Reviewer Support Ahead Of ODAC
This article was originally published in The Pink Sheet Daily
Executive Summary
Roche/Genentech’s HER2-targeted therapy pertuzumab has sufficient evidence for accelerated approval in neoadjuvant breast cancer, agency briefing documents conclude, but reviewers question use of an anthracycline-containing chemotherapy regimen.
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