Tykerb is now indicated in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer, that overexpresses the HER2 receptor for whom hormonal therapy is indicated. Tykerb, in combination with an aromatase inhibitor, has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.
The company said that Tykerb was already indicated in combination with Xeloda (capecitabine) for the treatment of patients with advanced or metastatic breast cancer, whose tumours overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.3
Tykerb, known as Tyverb in European markets, is currently being reviewed by the EMEA for a comparable indication through a supplemental marketing authorisation.
Reportedly, the double-blind, placebo-controlled study enrolled 219 women diagnosed with post-menopausal, HR-positive and HER2-positive metastatic breast cancer. Women treated with lapatinib and letrozole experienced a 5.2 month increase in median progression-free survival (PFS), as compared to women treated with letrozole alone.
Paolo Paoletti, senior vice president of oncology R&D at GSK, said: “This combination of Tykerb plus Femara is an example of advancing science and improving patient care. This regimen attacks two specific receptors that drive cancer growth. Women battling this disease now have the opportunity to delay the use of traditional cytotoxic-chemotherapy, which is an exciting possibility for them.”