The European Commission has granted additional indication for GlaxoSmithKline’s (GSK) Tyverb (lapatinib) in combination with trastuzumab for adult patients with overexpress HER2 (ErbB2), with hormone receptor-negative (HR-) metastatic breast cancer.
An orally administered small molecule, Lapatinib inhibits the tyrosine kinase components of the HER1 (ErbB1 or EGFR) and HER2 (ErbB2) receptors.
GlaxoSmithKline Oncology president Paolo Paoletti said, "Today's 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," Paoletti added.
The marketing authorisation was granted based on the results of the EGF104900 trial, which is a randomised, open-label, Phase III study of lapatinib + trastuzumab versus lapatinib monotherapy.
The trial's primary endpoint was progression-free survival (PFS), with overall survival (OS) as the secondary endpoint.
Lapatinib is not licensed for use as a monotherapy in Europe or elsewhere, while the drug candidate plus trastuzumab is approved for use in countries in the EU, Philippines, Russia and Thailand only.
Currently, Lapatinib is approved in 107 countries, including the US, Europe, Australia, India, Brazil, Russia, Turkey, South Korea and other countries around the world.
