RPT Genentech resubmits Avastin to FDA as breast cancer combination treatment |
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Published
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Fri, 24 Aug 2007 17:38
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(repeating to show Genentech is majority-owned by Roche; amends typo in graph 3)ZURICH (Thomson Financial) - Genentech Inc, which is majority owned by Roche Holdings AG, has resubmitted Avastin to the US Food and Drug Administration for the treatment of breast cancer in combination with paclitaxel for patients who have not received chemotherapy.The resubmission is based on a phase III trial and marks the beginning of a six-month review period by the FDA, said Roche.In Sept 2006 the FDA had asked Genentech for more information from the trial, including an independent review. The resubmission followed completion of the review.Earlier today Avastin received EU approval for the first-line treatment of patients with advanced non-small cell lung cancer in combination with platinum-based chemotherapy.sarah.fenwick@thomson.comsf/jms/sf/jsaCOPYRIGHTCopyright AFX News Limited 2007. All rights reserved.The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News.
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Genentech resubmits Avastin to FDA as breast cancer combination treatment 