European Commission has approved the use of Herceptin® (trastuzumab) in combination with Taxotere®

Jun 23 2004

Roche announced today that the European Commission has approved the use of Herceptin® (trastuzumab) in combination with Taxotere® (docetaxel) in the European Union as a first-line therapy in HER2-positive metastatic breast cancer patients who have not yet received chemotherapy for their disease.

HER2-positive breast cancer patients suffer from a particularly aggressive form of breast cancer which traditionally has a poor prognosis.

The approval is based on study results which showed that for women with HER2-positive breast cancer, the combination of Herceptin and Taxotere significantly improved median life expectancy by more than one-third (31 months with Herceptin plus Taxotere vs. 22 months for Taxotere alone). The study also showed that 61% of patients treated with the combination responded to treatment, compared to 34% of patients who received Taxotere alone.

"The early use of this new combination therapy represents a vital life-extending treatment option for patients, and highlights the critical importance of verifying HER2 status upon diagnosis of breast cancer," said William M. Burns, Head of Roche's Pharmaceuticals Division. "Now that this combination therapy will be made available to women across Europe, this further consolidates the position of Herceptin as the foundation of care in HER2-positive metastatic breast cancer."

In an earlier trial, Herceptin also showed a survival benefit when used as a first-line therapy in combination with Taxol® (paclitaxel). Both Taxol and Taxotere belong to the most commonly used class of chemotherapy agents for metastatic breast cancer in Europe, known as 'taxanes'. This trial with Herceptin and Taxotere firmly establishes Herceptin in combination with taxanes as the foundation of care for women with HER2-positive metastatic breast cancer.

The aggressive nature of HER2-positive breast cancer makes both the survival and response rates highly meaningful. In HER2-positive breast cancer, increased quantities of the HER2 (Human Epidermal growth factor Receptor 2) protein are present on the surface of the tumour cells. This is known as 'HER2 overexpression'. High levels of HER2 overexpression are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that HER2 overexpression affects approximately 20-30% of women with breast cancer.

Visit HER2status.com and heratrial.com for further information about Herceptin.