GlaxoSmithKline has been boosted by the news that European regulators have approved a new indication for its breast cancer treatment Tyverb.

The European Commission has granted a variation to its conditional marketing authorisation for Tyverb (lapatinib) which allows the drug to be used in combination with an aromatase inhibitor. Specifically the combo has been approved for the treatment of post-menopausal women with hormone receptor-positive, HER2 (ErbB2) over-expressing metastatic breast cancer for whom chemotherapy is currently not intended.

The latest green light is no surprise seeing as how the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion in February. That was based on Phase III results demonstrating that a combination of Tyverb and the AI letrozole provided a significant improvement in progression-free survival compared to letrozole alone (8.2 months versus three months). A combination of Tyverb, sold as Tykerb in the USA, and Roche's chemotherapy Xeloda (capecitabine) is already authorised in more than 90 countries.

However, earlier this month, the UK’s National Institute for Health and Clinical Excellence once again decided that the Tyverb/Xeloda combination is too expensive to be paid for by the National Health Service.