Herceptin receives positive opinion in Europe for use in combination with an aromatase inhibitor for the treatment of patients with HER2- and hormone receptor-positive metastatic breast cancer.
Roche announced that the European U_nion?s Committee for Human Medicinal Products (CHMP) has issued a positive recommendation for the use of Herceptin in combination with an aromatase inhibitor for the treatment of postmenopausal patients with HER2- and hormone receptor-positive metastatic breast cancer.
The recommendation is based on data from the international phase III TAnDEM study which showed that the addition of Herceptin to hormonal therapy doubles the median progression-free survival (time patients live without their cancer progressing), from 2.4 months to 4.8 months.1
Comprehensive reviews have suggested that approximately two thirds of breast tumours are hormone receptor positive2. Of these, a significant percentage (up to 25%) are also HER2-positive3,4,5
TAnDEM is the first randomised study to show that this specific subset of ‘co-positive’ patients (both HER2- and hormone receptor-positive) is ‘high-risk’, making the positive results with Herceptin even more meaningful.
“The results from the TAnDEM study show once again that Herceptin should be the backbone for all patients with HER2-positive breast cancer ? it consistently benefits patients regardless of whether it is given in the early- or advanced-stage settings, or whether it is in combination with chemotherapy, hormonal therapy, or as a single agent,” said Eduard Holdener, Chief Medical Officer of Roche. “This combination offers a new treatment regimen for patients who suffer from a particularly aggressive form of breast cancer, and we are pleased to have been able to progress this application so quickly.”
The positive opinion proposes the approval of Herceptin in this combination by the European Commission. Herceptin is currently approved for the treatment of early and metastatic (advanced) HER2-positive disease, and has demonstrated a survival benefit in both settings. The new approval will also allow Herceptin to be used in combination with hormonal therapy for advanced breast cancer.