GlaxoSmithKline submits Tykerb in US, EU for first-line use in breast cancer

GlaxoSmithKline announced Wednesday that it filed applications with regulators in both the US and EU to expand approval for Tykerb (lapatinib), in combination with an anti-hormonal therapy, as a first-line treatment in patients with hormone-sensitive, advanced or metastatic breast cancer.

The company said the regulatory submissions are based on previously released results from the EGF30008 study, which assessed the use of Tykerb plus Novartis' aromatase inhibitor Femara (letrozole) in women with hormone receptor-positive metastatic breast cancer that may or may not over-express the HER2-positive receptor.

The drug, which is marketed as Tyverb in Europe, is currently approved in the US and EU in combination with Roche's Xeloda (capecitabine) for patients with advanced or metastatic HER2-positive breast cancer who have received prior therapy.

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