GSK Withdraws Application for Tyverb Indication Extension

The decision to withdraw the application was based on the CHMP’s assessment that the lack of an active-controlled trial hampers the proper assessment of the benefit-risk balance in European patients in the applied indication.

The European Medicines Agency has been formally notified by GlaxoSmithKline Research & Development of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorised medicine Tyverb (lapatinib), 250 mg film-coated tablets.

On 14 April 2011, GlaxoSmithKline submitted an application to extend the marketing authorisation for Tyverb in combination with paclitaxel for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 (ErbB2). The patients in the registration study were not previously treated with trastuzumab in either the adjuvant or metastatic setting.

At the time of withdrawal, the application was under review by the Agency’s Committee for Medicinal Products for Human Use