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EC approves GSK's Tyverb for breast cancer

The European Commission (EC) has approved an additional use of GlaxoSmithKline's (GSK) Tyverb (lapatinib) as a treatment for breast cancer

The European Commission (EC) has approved an additional use of GlaxoSmithKline's (GSK) Tyverb (lapatinib), in combination with an aromatase inhibitor, as a treatment for post-menopausal women with hormone receptor-positive, HER2 over-expressing metastatic breast cancer and for whom chemotherapy is currently not intended.

The approval follows a positive recommendation by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in February 2010.

According to a consensus forecast compiled by Thomson Reuters, sales of Tyverb in the US (where the drug is sold as Tykerb), are expected to reach around $375m in 2014.

Earlier this month, draft guidance issued by the UK's National Institute for Health and Clinical Excellence (NICE), recommended against the use of Tyverb outside of clinical trials. 

In the US, the Food and Drug Administration (FDA) approved the expanded use of Tyverb in combination with Novartis' Femara (letrozole)  - an aromatase inhibitor, in February 2010.

24th June 2010

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