GSK withdraws Tykerb-Herceptin sNDA ahead of ODAC; awaiting more data
This article was originally published in Scrip
Less than two weeks before GlaxoSmithKline's supplemental new drug application (sNDA) for Tykerb (lapatinib) in combination with Genentech's Herceptin (trastuzumab) in treating patients with HER2 (ErbB2)-positive metastatic breast cancer previously treated with Herceptin was to go before the US FDA's Oncologic Drugs Advisory Committee (ODAC) for an up or down vote, the London drug giant yanked it.
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