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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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