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GSK Study Shows Tykerb/Herceptin Combo Increases Progression-Free Survival In Breast Cancer

This article was originally published in The Pink Sheet Daily

Executive Summary

Firm unveils positive Phase III data in women with HER-2 positive metastatic breast cancer weeks ahead of ASCO annual meeting.

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GlaxoSmithKline Pulls Tykerb sNDA Ahead Of FDA Panel Review

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.

GlaxoSmithKline Pulls Tykerb sNDA Ahead Of FDA Panel Review

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.

Tykerb/Herceptin Combination Will Go Before FDA Advisory Panel

FDA’s Oncologic Drugs Advisory Committee will review a combination of GlaxoSmithKline’s Tykerb (lapatinib) with Roche’s Herceptin (trastuzumab) that would offer patients with HER-2 positive metastatic breast cancer a chemo-free option.

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