Roche has filed its blockbuster Herceptin with regulators in the USA as a potential treatment for patients with advanced stomach cancer.

The Swiss firm’s Genentech unit has confirmed this morning that it has submitted a supplemental Biologics License Application to the US Food and Drug Administration for Herceptin (trastuzumab) plus chemotherapy in people with advanced, HER2-positive adenocarcinoma of the stomach, including gastroesophageal junction cancer. The drug is currently approved for breast cancer but also is available for the stomach indication in Europe.

The submission is based on results from a Phase III clinical trial showing that Herceptin, when given alongside chemotherapy (Roche’s own oral Xeloda [capecitabine] or intravenous 5-flourouracil and cisplatin), can significantly increase the survival of patients with HER2-positive gastric tumours, compared to those receiving chemotherapy alone (13.8 versus 11.1 months).

Hal Barron, chief medical officer at Roche, said the submission “reflects our commitment to developing more personalised medicines for people with cancer”. He added that “by using diagnostics to help identify the right patients for our medicines, it is our hope that Herceptin used with chemotherapy will become the first targeted option for advanced HER2-positive stomach cancer”.