GSK and Novartis withdraw EU extended use applications for Tyverb and Fluad, respectively

The European Medicines Agency has been formally notified by UK pharma giant GlaxoSmithKline (LSE: GSK) of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorized breast cancer drug Tyverb (lapatinib), 250mg film-coated tablets.

On April 14, 2011, GSK submitted an application to extend the marketing authorization 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 (CHMP).

Tyverb was given conditional approval and was first authorized in the European Union in June 2008. It is currently authorized for treatment of patients with breast cancer whose tumors overexpress HER2 (ErbB2):