Today the FDA Commissioner recommends revoking the Avastin label for metastatic breast cancer. As we’ve said before, the FDA is not:
- Pulling Avastin from the market;
- Banning use of Avastin for metastatic breast cancer;
- Punishing doctors who use it off-label;
- Banning reimbursement for off-label use; or
- Making a death panel decision based on inadequate scientific evidence.
Journalists & bloggers – no excuse for making these mistakes (again).
If you have questions about the FDA action, please read the key NEJM study first. Then read the FDA’s 69 page review of the scientific evidence. We’re interested in data here at TIE, so comments are welcome about the validity of the evidence base on this question.