Bevacizumab Gone: Where to From Here?
Bevacizumab Gone: Where to From Here?
Hi. This is Dr. Kathy Miller back with a quick Medscape Oncology video blog at the end of the bevacizumab in breast cancer era. We learned last Friday that the US Food and Drug Administration has made their decision final. They will revoke the indication for metastatic breast cancer. That decision is not really a surprise. We have all seen this coming after the Oncologic Drugs Advisory Committee hearings and the appeal hearings this last summer. Our only question was when they were going to announce this decision, but I would like to turn our eyes forward. How do we move forward from here?
First, we have to make certain that our patients are protected, that patients currently on therapy and doing well without toxicity are able to continue therapy. This brings a great deal of uncertainty. Will their insurance carriers now stop covering this agent? Hopefully that won't happen, and if it does we should all join in a call to the sponsor, to Genentech, to continue to make that drug available to those women. This ought to redouble our efforts to identify which patients are most likely to benefit. You will recall that the discussion was not about "is there benefit?" All of the trials met their primary endpoints with improvement in progression-free survival, improvement in overall response rate, but no difference in survival. The discussion was about toxicity. The argument was: when does the balance of benefit and risk shift to favorable vs unfavorable? Where we have failed is our ability to identify which patients should receive this drug. This is not a drug for which everybody receives benefit. Only some patients benefit, and we need to work harder to identify who those patients are.
We also need to initiate a national conversation. What do we want? What do we need? What do we expect? What do our patients want from treatment in the metastatic setting? From that discussion, what should it take to get drugs approved in the future? Right now, the approval process is cumbersome, and the criteria for approval are very subjective and very unclear. That puts us all in a difficult situation in figuring out how to design therapies and how to move them forward. I would welcome your thoughts on the end of this era and how we move forward. Or should we move forward with this agent in future studies? What do your patients want in the metastatic setting? What sort of drugs and what sort of benefits would you like to see studied and approved for your patients with metastatic breast cancer? I welcome your comments and thoughts on any of these topics.
Hi. This is Dr. Kathy Miller back with a quick Medscape Oncology video blog at the end of the bevacizumab in breast cancer era. We learned last Friday that the US Food and Drug Administration has made their decision final. They will revoke the indication for metastatic breast cancer. That decision is not really a surprise. We have all seen this coming after the Oncologic Drugs Advisory Committee hearings and the appeal hearings this last summer. Our only question was when they were going to announce this decision, but I would like to turn our eyes forward. How do we move forward from here?
First, we have to make certain that our patients are protected, that patients currently on therapy and doing well without toxicity are able to continue therapy. This brings a great deal of uncertainty. Will their insurance carriers now stop covering this agent? Hopefully that won't happen, and if it does we should all join in a call to the sponsor, to Genentech, to continue to make that drug available to those women. This ought to redouble our efforts to identify which patients are most likely to benefit. You will recall that the discussion was not about "is there benefit?" All of the trials met their primary endpoints with improvement in progression-free survival, improvement in overall response rate, but no difference in survival. The discussion was about toxicity. The argument was: when does the balance of benefit and risk shift to favorable vs unfavorable? Where we have failed is our ability to identify which patients should receive this drug. This is not a drug for which everybody receives benefit. Only some patients benefit, and we need to work harder to identify who those patients are.
We also need to initiate a national conversation. What do we want? What do we need? What do we expect? What do our patients want from treatment in the metastatic setting? From that discussion, what should it take to get drugs approved in the future? Right now, the approval process is cumbersome, and the criteria for approval are very subjective and very unclear. That puts us all in a difficult situation in figuring out how to design therapies and how to move them forward. I would welcome your thoughts on the end of this era and how we move forward. Or should we move forward with this agent in future studies? What do your patients want in the metastatic setting? What sort of drugs and what sort of benefits would you like to see studied and approved for your patients with metastatic breast cancer? I welcome your comments and thoughts on any of these topics.
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