GSK files two regulatory applications for tumor drug

GlaxoSmithKline has submitted two simultaneous regulatory applications to expand the use of Tyverb/Tykerb.

If approved, Tyverb/Tykerb could be used as a first-line therapy regimen combined with anti-hormonal therapy for patients with hormone-sensitive, metastatic or advanced breast cancer in Europe and the US.

The variation to the EU marketing authorization and the supplemental new drug application were submitted respectively to the European Medicines Agency and to the FDA for the combination of Tyverb/Tykerb plus an aromatase inhibitor based on the recent study, EGF30008.

This study evaluated Tyverb/Tykerb in combination with letrozole in women whose breast cancer expressed was hormone receptor positive and may or may not also over-expressed the HER2+/ErbB2+ receptor.

Debasish Roychowdhury, head of medicines development for oncology at GSK, said: Tyverb/Tykerb with a hormone therapy is a biologically-rational targeted treatment, since the combination attacks two specific receptors that drive the cancer growth.

If approved the combination could provide a cytotoxic chemotherapy-free option for these patients and we look forward to working with regulatory agencies to advance the availability of this regimen as a new, oral option for patients in first-line breast cancer.