GlaxoSmithKline Withdraws Application for Wider Tyverb Use
Published: Feb 16, 2012
The European Medicines Agency said on Thursday that GlaxoSmithKline had withdrawn its application to widen use of its cancer drug Tyverb after regulators said it would be difficult to make a judgment without an active controlled trial. The British drugmaker had wanted to extend the authorisation of the cancer drug, known generically as lapatinib, for use in combination with the chemotherapy drug paclitaxel for some breast cancer patients. Tyverb was approved in Europe in 2008 for use in combination with two other drugs - capecitabine and an aromatase inhibitor - for certain patients.