fda grants accelerated approval for bevacizumab

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Inpharma 1627 - 1 Mar 2008 FDA grants accelerated approval for bevacizumab The FDA has granted Genentech accelerated approval for bevacizumab [Avastin] in combination with paclitaxel as first-line therapy in patients with advanced HER2-negative breast cancer. A full review of the phase III AVADO and RIBBON-1 trial data by the FDA will be required for the accelerated approval to be renewed to a full approval. Roche is the licensee for this product. Roche. FDA grants accelerated approval of Avastin in combination with paclitaxel chemotherapy for first-line treatment of patients with advanced HER2-negative breast cancer. Media Release : 23 Feb 2008. Available from: URL: http:// www.roche.com 809085600 1 Inpharma 1 Mar 2008 No. 1627 1173-8324/10/1627-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: FDA grants accelerated approval for bevacizumab

Inpharma 1627 - 1 Mar 2008

FDA grants accelerated approvalfor bevacizumab

The FDA has granted Genentech accelerated approvalfor bevacizumab [Avastin] in combination withpaclitaxel as first-line therapy in patients with advancedHER2-negative breast cancer.

A full review of the phase III AVADO and RIBBON-1trial data by the FDA will be required for the acceleratedapproval to be renewed to a full approval. Roche is thelicensee for this product.Roche. FDA grants accelerated approval of Avastin in combination with paclitaxelchemotherapy for first-line treatment of patients with advanced HER2-negativebreast cancer. Media Release : 23 Feb 2008. Available from: URL: http://www.roche.com 809085600

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Inpharma 1 Mar 2008 No. 16271173-8324/10/1627-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved