GlaxoSmithKline is looking to get expanded approval on both sides of the Atlantic for its advanced breast cancer drug Tykerb/Tyverb.

GlaxoSmithKline has submitted two simultaneous regulatory applications to expand the use of Tykerb (lapatinib) as a first-line treatment combined with anti-hormonal therapy for patients with hormone-sensitive, metastatic breast cancer in Europe and the USA. The submissions are based on results from the recent EGF30008 study which evaluated 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.

Debasish Roychowdhury, head of medicines development of GSK Oncology, said that lapatinib with a hormone therapy “is a biologically-rational targeted treatment, since the combination attacks two specific receptors that drive the cancer growth”. He added that if authorised, the combo “could provide a cytotoxic chemotherapy-free option” and a new, oral treatment for patients in first-line breast cancer.

Tykerb is currently approved in 74 countries in combination with Roche's Xeloda (capecitabine) for patients with advanced or metastatic HER2-positive breast cancer who have received prior therapy. The drug had sales last year of $189 million and expanded approval would push that figure up considerably.

News of the filing came just after the European Commission approved GSK’s pneumococcal vaccine Synflorix for active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks up to two years of age.