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news.GlaxoSmithKline has announced that the European Commission has granted a conditional marketing authorization for Tyverb, the first oral, small molecule dual targeted therapy, for all 27 EU member states.
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GlaxoSmithKline’s Tyverb (lapatinib), in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress ErbB2.
The authorization was based on a pivotal Phase III trial (EGF100151) in which women with locally advanced or metastatic ErbB2-positive breast cancer whose disease had progressed following prior treatment with anthracyclines, taxanes and trastuzumab were given either the combination of lapatinib and capecitabine, or capecitabine alone.
The data showed that the investigator assessed median time to progression was 5.5 months (23.9 weeks) in the lapatinib and capecitabine arm versus 4.2 months (18.3 weeks) in the capecitabine arm alone. The independent assessment demonstrated that lapatinib when given in combination with capecitabine significantly increased time to progression by 6.2 months (27.1 weeks) compared to 4.3 months (18.6 weeks) with capecitabine alone (hazard ratio 0.57 p=0.001).
Paolo Paoletti, senior vice president and global head of the oncology medicine development centre at GlaxoSmithKline, said: “The authorization of lapatinib demonstrates our strong commitment to the discovery and development of novel anti-cancer treatments.”