GSK receives authorisation in the EU for breast cancer drug Tyverb (lapatinib)
GlaxoSmithKline (GSK) says the European Commission has granted a conditional marketing authorisation for Tyverb (lapatinib), the firstoral, small molecule dual targeted therapy, for all 27 European Union (EU) member states.
GlaxoSmithKline (GSK) says the European Commission has granted a conditional marketing authorisation for Tyverb (lapatinib), the firstoral, small molecule dual targeted therapy, for all 27 European Union (EU) member states.
Lapatinib, in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressive disease following prior therapy, which must include anthracyclines and taxanes, and therapy with trastuzumab in the metastatic setting.
Today's news means that GSK is able to make lapatinib available in the EU (subject to market access requirements) and the company is currently working with local regulatory authorities to ensure lapatinib is available to eligible patients as soon as possible.
Lapatinib has a novel mechanism of action that is different from current licensed targeted therapies for ErbB2-positive disease. It is a small molecule that is administered orally and works by getting inside the cancer cell and inhibiting two receptor proteins - the tyrosine kinase components of the ErbB1 and ErbB2 receptors. The signalling of these receptors is responsible for tumour growth and proliferation.
"Lapatinib will play a valuable role in treating this especially aggressive form of advanced breast cancer, with the added benefit of convenience being a pill rather than needing intravenous administration. said professor David Cameron, co-principle investigator of the Phase III trial.