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Herceptin approved for stomach cancer

Genentech's breast cancer drug Herceptin has won US approval for a type of stomach cancer for which there are limited therapeutic options

Genentech's targeted biologic medicine Herceptin (trastuzumab), which has been marketed in the US as a treatment for HER2-positive breast cancer for more than a decade, has won US Food and Drug Administration (FDA) approval as a treatment for a type of stomach cancer for which there are few other options.

Specifically, the new approval covers Herceptin in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil) for HER2-positive metastatic cancer of the stomach or gastroesophageal junction in male and female patients who have not received prior medicines for their metastatic disease.

HER2-positive disease, in which human epidermal growth factor receptor 2 is over-expressed, is the only kind of stomach cancer that may be treated with Herceptin under the approval.

The FDA's approval follows the European Commission's (EC) January approval for essentially the same indication. The approvals were based on an international phase III study showing that stomach cancer patients who received Herceptin plus chemotherapy lived longer compared to those who received chemotherapy alone.

The study enrolled 594 people with locally advanced or metastatic, HER2-positive stomach cancer. It demonstrated that Herceptin plus chemotherapy improved overall survival by 37 per cent compared to chemotherapy alone.

Genentech estimates that approximately 22 per cent of people with advanced stomach cancer have HER2-positive tumours.

22nd October 2010

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