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Genentech/Roche gain 1st FDA win in pre-surgery breast cancer with Perjeta

This article was originally published in Scrip

Executive Summary

Genentech's Perjeta (pertuzumab) won the US FDA's nod on 30 September as the first treatment for HER2-positive early-stage breast cancer in the neoadjuvant, or pre-surgery, setting – gaining the agency's blessing under an accelerated approval a month ahead of its 31 October Prescription Drug User Fee Act action date.



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