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news.Roche has said the European Union's Committee for Human Medicinal Products has issued a positive recommendation for the use of Herceptin for the treatment of HER2-positive and hormone receptor-positive breast cancer.
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The recommendation is based on data from the phase III study which showed that the addition of Herceptin to hormonal therapy doubles the median progression-free survival, from 2.4 months to 4.8 months.
Comprehensive reviews have suggested that approximately two thirds of breast tumors are hormone receptor-positive. Of these, up to 25% are also HER2-positive. This is the first study to show that this specific subset of 'co-positive' patients is 'high-risk', making the positive results with Herceptin even more meaningful.
“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,” said Eduard Holdener, chief medical officer of Roche.
The new approval will allow Herceptin to be used in combination with a hormonal therapy for advanced breast cancer.