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Lapatinib (Tykerb®) has been approved in Switzerland, its first European market, in combination with capecitabine for treating patients with advanced breast cancer, and in women with HER-2 positive breast cancer who are unresponsive to therapy with trastuzumab (Herceptin®).
Approval was based on a pivotal phase III trial in women with breast cancer which found that a combination of lapatinib and capecitabine was associated with better progression-free survival than capecitabine alone (27.1 vs 18.6 weeks). Analysts suggest that lapatinib looks set to face a battle for market share with trastuzumab and that it may have an advantage in being an oral agent.
PharmaTimes 24/5/2007