Avid Bioservices Inc (CDMO): FDA grants Roche Holding AG's Genentech'...

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Wednesday, 07/23/2014 5:28:02 AM

Wednesday, July 23, 2014 5:28:02 AM

FDA grants Roche Holding AG's Genentech's Avastin priority review for recurrent platinum-resistant ovarian cancer
22-Jul-2014 07:25
Roche Holding AG:
• Genentech, a member of the Roche Group says that U.S. Food and Drug Administration (FDA) has accepted the company's supplemental biologics license application (sBLA)
• And granted priority review for Avastin (bevacizumab) plus chemotherapy for treatment of women with recurrent platinum-resistant ovarian cancer
• Designation of priority review status is granted to medicines that FDA believes have potential to provide 'significant improvements in safety or effectiveness of treatment, diagnosis, or prevention of serious conditions when compared to standard applications
• SBLA for Avastin plus chemotherapy for recurrent platinum-resistant ovarian cancer is based on data from Phase III AURELIA trial with FDA action date of Nov. 19