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GSK files Tyverb MAA with EMA

GlaxoSmithKline (GSK) has filed a marketing authorisation application (MAA) with the European Medicines Agency (EMA) for Tyverb (lapatinib) in conjunction with paclitaxel.

Lapatinib is an oral small-molecule inhibitor of the EGFR and ErbB2 (HER2) tyrosine kinase receptors.

The company seeks the approval for Tyverb as a treatment for the patients who are suffering from metastatic breast cancer whose tumours over-express HER2 (ErbB2).

So far, GSK has received approval for Tyverb/Tykerb in 90 countries including the EU, Switzerland, US, Canada, Japan, Australia and countries in South America and Asia.