Google “Genetech wins U.S. approval to use Avastin to treat breast cancer” for the International Herald Tribune article.
It is not clear why they reversed their decision, which was 5-4 against avastin. There is no indication that it had now been proven to lengthen survival time nor that the problems that led the FDA to reject avastin earlier (among them deaths related to the drug) had been addressed.
Personally, I only get excited about a drug when I hear of someone at least one person getting rid of all signs of their secondary cancer, and I have heard of that happening with ixempra (although it came back two years later in the patient) and with ppar inhibitors, which are also in the pipeline, but so far not from avastin.
You are my first!! (newly registered - I had started a discussion headed “parp inhibitors” and got no response - feeling a bit like “Billy No Mates”!! ). Can you tell me everything you know or have heard about parp inhibitors?? I have read all the stuff Kudos Pharma have published but can find nothing more. My knowledge is v limited and I would be grateful for any info.
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It is accepted that Avastin isn’t a cure, but the benefits with regard to disease free time are significant.
The results of the E2100 trial show that patients receiving Avastin and a paclitaxel had a median progression-free survival of more than one year (13.3 months) compared to 6.7 months for those given paclitaxel alone.
There were over 700 women in this survey. The vast majority saw some benefit, either shrinkage or stabilisation, although a handful had to pull out because of extreme side effects. When I last read about it, there were still just under 10% of women who, after two years, were in remission.
In my view, this doesn’t represent a breakthrough, but it does represent hope. There are many other drugs that work in a similar type to Avastin just about to go into development so hopefully the science will get better.
As for why the decision was overturned, I heard that two members of the advisory panel changed their mind and wrote to the FDA to ask for their vote to be changed. Don’t know what evidence they based this on but I guess they thought, on balance, it was better to make Avastin available than to deny it to those for whom it might make a difference.
The manufacturers are being given an “accelerated approval” for Avastin, which means they will have to provide further evidence of its effectiveness and safety above and beyond the original study before they get full approval. That’s why there are lots of other studies underway, including the Athena trial that I am on.
In my mind, I am grasping at whatever time I can get disease free in the hope that other things come along that may be even better. Going through the chemo is rubbish, but if it gives me a year and a bit of good living at the end of it then in my view that’s worth going for. But others will, I am sure, have different views.
I don’t really know what to think about avastin though it raises many issues about treatments for advanced and metastatic breast cancer.
From what I can make out the original FDA decision was made by an advisory committee which voted 5 to 4 against approval… so a close one any way. Don’t know if members of the advisory committee changed their minds but the decision on Friday was made by the main FDA. (Federal Drug Adminsitartion…the body in the USA which approves drugs). It seems that in the major trials avastin did improve disease free survival as Deirdre says but did not improve overall survival (those on taxol alone lived a median of 24.8 months and those on avastin and taxol lived a median of 26.5 months. this difference, though better for the avastin group, is not considered statistically significant.) Reports I have read also say that avastin did not improve quality of life which I think is significant, though I’m puzzled as to whether the improvement in progression free survival wouldn’t have improved symptoms?? Apparently about 6 people died of the side effects of avastin…another argument against it.
I understand what Deirdre is saying about hope…and how the potential for improved progression free survival may give hope that something else will be discovered in the meantime. Realistically though I’m not sure if this is the case…
Christine…not sure that ixempra has been approved for use in the UK…does anyone know?
PARP inhibitors…don’t know much about them except there are some early trials and they are drugs targetted at BRCA1 and BRCA2 cancers. Since most BRCA1 tumours are triple negative PARP inhibitors may have a particualr role for triple negatives in general…which reminds me that some peopkle think avastin might be most helpful for triple negative disease…but is this wishful and desperate thinking?
Like you Christine I’m not very excited by any of the possibilities for treating advanced breast cancer. Herceptin seems to be a ‘wonder drug’ for those for whom it works, and tamoxifen and aromatase inhibitors similarly.
I agonise daily over bothering with chemotherapy. It is 10 months now since my regional recurrence…cancer is still active in my chest wall and supra and infra clavicular nodes but its no worse than a year ago…and I am still NED in major organs…but I have spent most of the last 10 months on chemo of one kind or another…half of that feeling too tired to be bothered…and my intellect rebels all the time as to ‘why bother’. I guess those who love me would rather I was here tired for longer than not here at all…but quite honestly I often think I’d prefer shorter well time…sorry if that sounds heretical. I still keep taking the chemotherapy because I’m too scared not to…and thats what people do.
I would agree with Jane that most BRCA1-deficient carcinomas are triple negative, but it does not follow in reverse that most triple negative disease exhibits BRCA-deficiency.
This is taken from an online article. I’m not sure if I am allowed to post the link or not; may be the mods can advise?
Yes thats right. Most triple negatives are not BRCA1 (though I have a personal hunch that more triple negatives may have genetic deficiencies not yet discovered…just a hunch…no facts!
I am quite excited and keen to see Ixempra trialled/approved in the UK as it is has shown effectiveness in treating cancers which are anthracycline/taxane/capecitabine resistant i.e. for heavily pre-treated breast cancer. If you register with Nature, you can access some interesting reviews. I thought I had read of UK trials but cannot find them now.