The controversy over the breast cancer indication for Avastin (bevacizumab) culminated in June when the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted after an unusual and emotional 2-day hearing to uphold a prior recommendation to withdraw the label indication.
Joyce A. O’Shaughnessy, MD
On the Avastin Data
The front-line Avastin trials in metastatic breast cancer— three large, randomized trials—all met their primary endpoint of progression-free survival. They did not meet the endpoint of overall survival, but that wasn’t their primary endpoint. Nor were these trials really powered for survival in terms of picking up small benefits.
On the Safety of Avastin
I think Avastin in first-line therapy for metastatic breast cancer is very safe, as physicians are now accustomed to avoiding Avastin use in patients who have the possibility of complications (ie, patients with recent surgery, diverticulitis, any kind of active wound in the body, or with baseline uncontrolled hypertension).
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