US Regulatory Update – Tykerb® (lapatinib)

Issued: London UK

GlaxoSmithKline plc announced today that it has withdrawn a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Tykerb (lapatinib) in combination with trastuzumab for the treatment of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 us.gsk.com/html/medicines/index.html to view the full Tykerb US Prescribing Information including BOXED WARNING risk for hepatotoxicity and the Tyverb EU Patient Information Leaflet.

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GlaxoSmithKline cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.