Monday, 23 September 2019

GSK's cancer drug gets EU marketing authorization

16 August 2013 | Regulatory | By BioSpectrum Bureau

GSK's cancer drug gets EU marketing authorization

GSK's cancer drug gets EU marketing authorization

Singapore: European Commission has granted an additional indication for GlaxoSmithKline's Tyverb (lapatinib) to be used in combination with trastuzumab.

This combination is indicated for adult patients with breast cancer whose tumours overexpress HER2 (ErbB2), with hormone receptor-negative (HR-) metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy.

"The announcement is important for women with this specific type of metastatic breast cancer, who will have now a new treatment option. The combination of Tyverb and trastuzumab, which is chemotherapy-free, has the potential to make a positive impact on the care and survival of these patients," said Mr. Paolo Paoletti, President, GlaxoSmithKline Oncology.

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