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Avastin resubmission

Executive Summary

Genentech appears on target for a February user fee date on its resubmitted sBLA for Avastin (bevacizumab) as a first-line treatment for metastatic breast cancer in combination with paclitaxel. The firm announced the resubmission Aug. 24 and expects a six-month review. FDA requested an independent review of patient scans for progression-free survival in a "complete response" letter it sent to the firm Sept. 8 (1"The Pink Sheet" Oct. 2, 2006, p. 21). Genentech said the independent review results were consistent with its earlier positive findings...
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