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Kadcyla Manufacturing Review Was A Production In Itself

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The complex manufacturing required by Genentech’s antibody-drug conjugate trastuzumab emtansine pushed FDA’s review two months past the agency’s internal action timetable, required four review teams from three CDER offices and produced a veritable blizzard of information requests. But is that level of intensity sustainable as the expanding ADC pipeline matures?

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