Regulators have approved a combination of GlaxoSmithKline's Tyverb and Roche's Herceptin for use within the European Union, offering a new chemo-free option for the treatment of metastatic breast cancer.
The European Medicines Agency has given the go-ahead for its use in adults whose tumours over-express HER2 (ErbB2) with hormone receptor-negative (HR-) metastatic disease that has advanced despite prior treatment with a Herceptin/chemotherapy combo.
Tyverb (lapatinib) is a tyrosine kinase inhibitor and Herceptin (trastuzumab) a monoclonal antibody, and together they target the same HER2 receptor at different points to improve its blockade, potentially achieving better pathway inhibition than either compound could induce alone, GSK said.
Indeed, post-hoc analysis of data from the Phase III EGF104900 study, on which EU approval was based, showed that the combination of these drugs was associated with an 8.3 month increase in median overall survival versus Tyverb therapy alone.
"Through vertical dual blockade of the HER2 receptor, the combination of lapatinib and trastuzumab achieves a clinically significant improvement in overall survival for patients with HER2-positive, HR-negative metastatic breast cancer,” said Dr Pim Kon, UK Medical Director, GSK, and noted that the combination "has the potential to make a meaningful impact on the care and survival of women in this breast cancer population.”