There should be a decision soon on the controversial Avastin-for-metastatic-breast-cancer indication. I’ve written about that several times here, and my position is unchanged: the preliminary clinical data made it worth a provisional approval, but the follow-up data didn’t back it up. This happens. The provisional approval should, I think, be withdrawn, because based on the best evidence we have (which is a lot more than we had when the approval was granted), Avastin is not effective for metastatic breast cancer, and carries notable risks all its own.
Now, via NPR’s Scott Hensley, I see that one of the members of the FDA’s committee on this issue has published a letter in the New England Journal of Medicine explaining his vote. Says Mikkael Sekeres of the Cleveland Clinic:
“The responsibility of ODAC is to carefully consider the scientific data presented as part of an FDA application for a cancer drug and weigh the benefits that the drug may provide to patients with cancer against the risks posed by the drug’s side effects. We try to be dispassionate, but we always think about the person we face in clinic sitting a foot or two away from us in our cramped examination rooms, waiting to hear what treatment we can offer to get rid of her cancer. What kind of conversation would I have with such a patient if I were trying to convince her to take a treatment like this?
“Well, I can offer you a drug that will not make you live longer, won’t make you feel better, and may have life-threatening side effects, but it will keep your cancer from worsening by an average of 1 to 2 months.”
Hope? Or false hope?”
Survival is the first thing you have to consider with a cancer therapy. And right next to it comes quality of life, because extending someone’s life for a brief period at the cost of horrible side effects is no bargain, either. Should women with metastatic breast cancer take Avastin? It does not, as far as anyone can tell, extend their lives. And it does not improve their quality of life – if anything, it makes it worse. Avastin can be a good drug against other forms of cancer, but it’s not for this one. I very much hope the FDA follows the recommendation of the advisory panel.