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GlaxoSmithKline Pulls Tykerb sNDA Ahead Of FDA Panel Review

This article was originally published in The Pink Sheet Daily

Executive Summary

The sponsor withdrew the application for combination use of lapatinib with Roche’s Herceptin in breast cancer less than two weeks before a scheduled advisory committee review, because of questions from FDA “that could not be addressed with the data currently available.” Those questions may have been driven by concerns about the clinical meaningfulness of a four-week median progression-free survival benefit and other efficacy issues.

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