Roche: Additional Licence Application For Avastin Filed In US

BASEL -(Dow Jones)- Swiss pharmaceutical company Roche Holding AG (ROG.VX) Tuesday said its U.S. unit Genentech has submitted two supplemental Biologics License Applications to the U.S. Food and Drug Administration for Avastin, or bevacizumab, for the treatment of women who have not received chemotherapy for advanced HER2-negative breast cancer.

MAIN FACTS:

- One aplication is based on the phase III AVADO study that investigated Avastin in combination with docetaxel chemotherapy. The other is based on the phase III RIBBON-1 study that investigated Avastin in combination with a taxane or anthracycline-based chemotherapy or the oral chemotherapy, Xeloda, or capecitabine. Both studies met their primary endpoints of improving the time women lived without the disease worsening.

Company Web site: http://www.roche.com

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November 17, 2009 01:38 ET (06:38 GMT)

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