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Randomization Required: Liver Signal Necessitated Kadcyla Trial With Control Arm

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A pivotal trial with a control arm was necessary to evaluate a hepatotoxicity signal with Genentech’s Kadcyla, helping to derail a bid for accelerated approval based on a single-arm Phase II trial. Genentech’s strategy of running trials in different lines of treatment concurrently enabled a quick strategy shift as an ongoing controlled Phase III trial in another line was amended to meet FDA’s regulatory requests.

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