GlaxoSmithKline (GSK) confirmed yesterday that the European Commission has granted a variation to the conditional marketing authorisation for Tyverb (lapatinib) in the European Union for a new therapeutic indication. Tyverb, in combination with an aromatase inhibitor, is indicated for the treatment of post-menopausal women with hormone receptor-positive, HER2 (ErbB2) over-expressing metastatic breast cancer and for whom chemotherapy is currently not intended. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor.
Source: GlaxoSmithKline