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Herceptin approved in Europe for use in combination with an aromatase inhibitor for the treatment of patients with HER2 and hormone receptor-co-positive metastatic breast cancer


The first combination of targeted therapies for any cancer to receive approval worldwide

Roche announced today that the European Commission has approved the use of Herceptin in combination with an aromatase inhibitor for the treatment of postmenopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer.
The approval is based on data from the international phase III TAnDEM study which showed that the addition of Herceptin to hormonal therapy doubled the median progression-free survival (time patients live without their cancer progressing), from 2.4 months to 4.8 months.1
“Today’s approval means that for the first time a combination of targeted therapies is available for patients who suffer from a particularly aggressive form of breast cancer,” commented William M. Burns, CEO Division Roche Pharmaceuticals. “Herceptin 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.”

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-positive.3, 4, 5. TAnDEM is the first randomised study to show that this specific subset of patients with ‘co-positive’ disease (both HER2- and hormone receptor-positive) are at an increased risk of relapse, making the positive results with Herceptin even more meaningful.

Herceptin is currently approved for the treatment of early and metastatic (advanced) HER2-positive disease, and has demonstrated a survival benefit in both settings. This new approval will also allow Herceptin to be used in combination with hormonal therapy for advanced breast cancer.


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