GSK's Tyverb gets first European approval with nod from Swissmedic

UK drug major GlaxoSmithKline says that its oral ErbB1 and ErbB2 dual inhibitor, Tyverb (lapatinib), has been approved in combination with capecitabine by Switzerland's regulatory authority, Swissmedic, for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress ErbB2 and who have relapsed after, or not responded to, treatment with Roche's Herceptin (trastuzumab). This approval was based on a pivotal Phase III trial (EGF100151) in women whose disease had progressed following treatment with trastuzumab and other cancer therapies. The data showed that the median time-to-progression was 27.1 weeks on the combination of Tyverb and capecitabine versus 18.6 weeks on capecitabine alone (p=0.0001), while the response rate was 23.7% vs 13.9% (p=0.017). Further launches across Europe are expected in the second quarter.