The EMA has granted a new indication for GSK’s oral breast cancer treatment Tyverb (lapatinib).
Approval was given for Tyverb, in combination with an aromatase inhibitor (AI), to treat post-menopausal women with hormone receptor (HR)-positive, ErbB2 (HER2) over-expressing metastatic breast cancer, based on evidence that it can increase progression-free survival (PFS) by more than five months in this indication.
Professor of Breast Cancer Medicine, Stephen Johnston, Royal Marsden NHS Foundation Trust & Institute of Cancer Research, commented: “Lapatinib plus an AI offers an effective, chemotherapy-free and well-tolerated option for patients with a distinct disease profile. As a first line option for these patients it offers a choice to delay the need for more aggressive and toxic therapies, such as chemotherapy. Importantly as an all-oral treatment option it allows patients to take their medication at home, relieving precious hospital resources.”
As an oral treatment, Tyverb has the potential to relieve hospital resources, but also to allow patients more time at home with their families.
Around 50% of patients with ErbB2-positive metastatic breast cancer are also HR-positive. A phase III trial in over 1200 patients demonstrated that ErbB2-positive patients given lapatinib plus letrozole experienced a median 8.2 months of PFS, compared with 3 months without lapatinib.
Lapatinib is already indicated (in combination with Xeloda/capecitebine) for patients with ErbB2-positive metastatic breast cancer, pretreated with anthracyclines and taxanes, who have progressed following treatment with trastuzumab in the metastatic setting. NICE, however, recently ruled that the drug is not a cost-effective use of NHS resources in this indication.
Tyverb in combination with letrozole is currently being considered by the NICE work programme as part of a Multiple Technology Appraisal (MTA) – guidance is expected in the first half of 2011.