November 17, 2009 / 7:15 AM / 10 years ago

UPDATE 1-Roche applies for Avastin advanced breast cancer use

* Roche unit submits two applications to U.S. FDA

* Avastin plus chemotherapy boosts survival rates-studies

(Adds detail, background)

Zurich, Nov 17 (Reuters) - Swiss drugmaker Roche Holding AG ROG.VX said on Tuesday its Genentech unit had submitted two applications for using Avastin to treat women for advanced breast cancer to the U.S. Food and Drug Administration.

Avastin is an antibody that helps control tumour growth by binding and blocking the biological effects of vascular endothelial growth factor, a driver of the process necessary for a tumour to spread to other parts of the body.

Roche said the two supplemental Biologics License Applications were for treating women who had not received chemotherapy for advanced breast cancer.

Each license application was based on a study, which both demonstrated that Avastin plus commonly used chemotherapies — taxane-based chemotherapy, anthracycline-based chemotherapy and capecitabine — increased the time women lived without the disease growing or spreading, compared with using the chemotherapies on their own, the company said.

In both studies, no new Avastin safety signals were observed.

Reporting by Catherine Bosley; Editing by Erica Billingham

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