US Regulatory Update – Tykerb® (lapatinib)

GlaxoSmithKline plc announced today that it has withdrawn a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Tykerb (lapatinib) in combination with trastuzumab for the treatment of patients with HER2 (ErbB2)-positive metastatic breast cancer who have received prior trastuzumab therapy. Regulatory reviews are ongoing in the European Union and other regions.

“Our discussions with FDA highlighted questions that could not be addressed with the data currently available.” said Rafael Amado, Head of Oncology R&D for GlaxoSmithKline. “We have decided to withdraw our application in the US with the intent to wait for ongoing studies testing the combination of lapatinib with trastuzumab.”

For information about the currently licensed indications for Tykerb/Tyverb, please visit http://www.gsk.com/products/prescription-medicines to view the full Tykerb US Prescribing Information including BOXED WARNING risk for hepatotoxicity and the Tyverb EU Patient Information Leaflet.