Roche wins EC approval for wider use of cancer drug Herceptin

The European Commission (EC) has approved Roche's Herceptin (trastuzumab) for patients with early-stage HER2-positive breast cancer following surgery and standard chemotherapy.

Herceptin was previously approved in the EU for the treatment of advanced (metastatic) HER2-positive breast cancer, so this new approval gives women with all stages of this aggressive disease, including early-stage breast cancer, access to this treatment.

HER2-positive cancer affects approximately 20% to 30% of women with breast cancer and requires immediate attention because the tumours are fast-growing and there is a higher likelihood of relapse.

The EC's approval is based on favourable results from the international HERA (HERceptin Adjuvant) study, which showed Herceptin following standard chemotherapy reduces the risk of cancer coming back by 46% compared with chemotherapy alone.

William Burns, ceo of Roche's Pharmaceuticals Division said: "Herceptin has clearly demonstrated that it provides the best chance of long-term survival when used as early as possible in the course of the disease, and this decision is great news for patients and the medical community. We will now work with national authorities to ensure that this treatment is accessible to physicians and patients throughout Europe."

Herceptin is marketed in the US by Genentech, in Japan by Chugai and internationally by Roche. It was recently granted approval in New Zealand and Australia, and several countries over the past year have developed clinical guidelines and committed funding to allow eligible patients faster access, prior to license. In the US, Genentech filed a supplemental Biologic License Application (sBLA) for the use of Herceptin in early-stage HER2-positive breast cancer with the Food and Drug Administration on February 15th, 2006.

Each year more than a million new cases of breast cancer are diagnosed worldwide, with a death rate of nearly 400,000 people a year. In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. High levels of HER2 are present in a particularly aggressive form of the disease, which responds poorly to chemotherapy. The humanised antibody Herceptin is designed to block the function of HER2.