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Feb 28, 2011
 |  BC Week In Review  |  Clinical News  |  Regulatory

Avastin bevacizumab regulatory update

FDA granted a hearing on June 28-29 to allow Genentech to present arguments for maintaining accelerated approval of Avastin bevacizumab for first-line treatment of HER2-negative metastatic breast cancer. The Roche unit requested a hearing in December after FDA proposed to remove the indication (see BioCentury, Jan. 3).

In a letter to the company, CBER Director Karen Midthun, who will be the presiding officer at the hearing, said FDA's Oncologic Drugs Advisory Committee will be present at the hearing to review the issues and provide advice and recommendations to the commissioner's office. ODAC has twice...

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