Genentech resubmits Avastin for breast cancer
This article was originally published in Pharmaceutical Approvals Monthly
Genentech expects a six-month review for its resubmitted Avastin (bevacizumab) sBLA for first-line treatment for metastatic breast cancer in combination with paclitaxel. The firm announced the resubmission Aug. 24. FDA requested an independent review of patient scans for progression-free survival in a "complete response" letter it sent to the firm Sept. 8. Genentech said the independent review results were consistent with its earlier positive findings...
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