Avastin/FDA

This is a tough one, Beth. I guess I might not be the best to answer as it seems I'm never moving on.

My read of Avastin, a monoclonal antibody targeting VEGF (vascular endothelial growth factor) which a goodly number of advanced breast tumors are positive for, is that it complimented the chemotherapy in a sufficient manner to allow a significant progression free period (phase 3 trial I think it was 5 months of PFS).

This is a new concept, progression free, to me. One which represents a much needed yardstick towards ultimately turning metastatic disease into a series of collective progression free yardsticks long enough to turn metastatic into a chronic disease.

The patient's who participated in this landmark trial (landmark in the sense of confirming that anti vascular therapies may compliment chemotherapy) were very sick, and of those who's death was attributed to Avastin (5/12 I believe), blood clot, stroke, MI was involved.

So.... there was a benefit of 5 months of additional freedom from disease progression weighted down by the death of participants from Avastin effects. Who is to say the end did not benefit the means, and who is to say it did? This is partially an ethical question and may be interpreted differently by each of us, let alone the advisors to the FDA.

It was these kinds of studies which trumpeted genuine progress in cancer therapy. But when you're the one who dies from the SE, well, going in you must be very sure you are accepting of this, and perhaps acknowledging your role in ultimately saving others down the road.

The FDA's ruling brings much needed discussion. This may be a short step backwords now which may motivate researchers and patients alike to join together to pave the road some more.

This is just my opinion, and I grieve, as a woman with breast cancer, for all the women who died while participating in the Avastin landmark study.

Tender

I didn't see that, but I know insurance is covering avastin for mets patients whether the FDA says yes or not.  To me that is more important.  That is bad when the insurance companies are behind the drug before the FDA.