GlaxoSmithKline announced the submission of a supplemental New Drug Application (sNDA) to the FDA for the use of Tykerb (lapatinib) tablet as a first-line therapy regimen combined with anti-hormonal therapy for patients with hormone-sensitive, metastatic (or advanced) breast cancer. This sNDA submission is based on a recent study evaluating Tykerb in combination with letrozole in women whose breast cancer was hormone receptor positive (HR+) and may or may not also over-express the HER2+/ErbB2+ receptor.

Tykerb is an oral small-molecule inhibitor of the HER2/ErbB2 tyrosine kinase receptor.

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