Better Get Your Avastin Gameface On: Patients to Testify Next Week

This remarkable and moving video was made by an Avastin patient’s 19-year-old son. What an amazing young man.

In as much as someone with an incurable disease can be fortunate, I am. My type of breast cancer (ER/PR+; HER2-) has many treatment options. I hope to get a good run out of  Tamoxifen and other antiestrogen options. (I just take a pill. I don’t have the harsh side effects associated with chemo.)  Someday I’ll need chemo. But not now.

Triple-negative breast cancer does not respond to Tamoxifen,  aromatase inhibitors or therapies that target HER2 receptors, such as Herceptin (trastuzumab). Most Stage IV people with triple-negative  metastatic breast cancer face a grueling (and fairly constant) chemo regimen. Some have had good results with Avastin. (I’m not a doctor. When I say “good” I mean they have a good quality of life with minimal side effects. See above video.)

Late in 2010,  the FDA  announced it wanted to  withdraw its earlier approval for Avastin as a treatment for advanced breast cancer. Genentech challenged the agency—an unusual move because most drug makers opt to voluntarily comply with the FDA in such cases, according to the WSJ.

The FDA will conduct its Avastin hearing  June 28-29, 2011 in the Great Room on the FDA White Oak Campus in Silver Spring, MD. The panel will hear competing interpretations of medical data about Avastin’s effectiveness in delaying the spread of late-stage breast tumors.

They’ll also hear from patients. Many, like Arlene Kalley of Michigan, have no other treatment option. They’ve tried everything else. Kalley’s husband Terry  founded FAMEDS  in response to the FDA’s  Avastin’s decision.  Kalley’s wife, Arlene has been an Avastin patient for more than two years and her medical team ascribes her longevity and quality of life to Avastin “Denying Avastin to these woman [with metastatic breast cancer]  is akin to denying someone food and water,” says Terry.

Avastin was first approved in 2004 for treatment of advanced colon cancer and has been approved since for advanced lung (2006), kidney and brain (glioblastoma) cancers (2009). Avastin was approved for metastatic breast cancer in 2008 under the accelerated approval program. Avastin is big business. Reportedly it is the No. 1 cancer drug in the world, generating $6 billion in revenues for Genetech last year, with breast cancer accounting for about $1 billion of that figure.

Avastin costs about $88,000 for a series of injections. In 2008, it won accelerated approval from the FDA in 2008 for treating advanced breast cancer after a Genentech-supported study showed that it delayed tumor regrowth by about five months. Much of the debate centers on replicating these results and weighing the not trivial side effects.

But what choice does someone like Arlene Kalley have? What would you do if you had triple-negative metastatic breast cancer?

On the heels of the FDA’s  decision to begin the process of reversing the first-line indication for bevacizumab in breast cancer, Dr. Kathy D. Miller raised some interesting  questions.

Miller is  the principal investigator of 2 of the trials reviewed by the FDA, including the Eastern Cooperative Oncology Group (ECOG) 2100 trial which showed the largest benefit and resulted in the original accelerated approval. “I have been very involved in these discussions and I am clearly conflicted here,” says Miller. “So, for those of you who are concerned about potential bias in my comments, it is probably time for you to stop listening now and I understand your concerns.”

Miller went on to say:

I would like to talk, though, about the bigger picture and not about the details of this agent and studies… I think we are so long overdue for a much larger and deeper discussion …what do our patients want from therapy for metastatic breast cancer?

Living better can encompass many different things for many different patients. It can include palliating symptoms for those who have symptoms. It can include avoiding or delaying the development of symptoms for those who are asymptomatic. It also includes minimizing the potential toxicities and the potential cost of therapies.

Our difficulty is that many of those endpoints are quite subjective. Our clinical trials are not very good at telling us how we are doing at meeting those objectives and the level of improvement that patients might find worthwhile can be quite different from patient to patient.

My biggest concern in all of this is ignoring the cost. I was astounded that the FDA press release specifically said cost had no bearing here. Having been at an original Oncology Drugs Advisory Committee (ODAC) hearing and reading the transcripts of the second ODAC hearing that is just not a believable contention. Certainly cost was not part of the formal review criteria, but if you read the ODAC transcripts, it was the elephant in the room. It was clearly present. It was clearly on the mind of the reviewers in the questions that they asked. If you read the commentaries in the news reports afterwards, cost was there and there is no question that this is a ridiculously expensive drug.

What concerns me is not allowing our patients to make decisions about level of benefit and cost by putting those together. Here, I think, we could perhaps take a lesson from our European colleagues who have separate reviews. First, simply a review of what are the benefits of this drug, what are the side effects, is this a drug that in some settings for some patients might be worthwhile? There has been a completely separate, honest, upfront directed review. What does this cost? Is this benefit something we are willing to pay for with our money for this cost? My worry is that in the United States those issues are all mixed up and jumbled and that makes the discussions more difficult and inherently less honest.

So, here is my plea. Regardless of what happens with bevacizumab and breast cancer, it is time for us to have an honest discussion. What do we want from our medicine in these different situations? What should it take to get a drug approved? Those issues ought to be consistent from study to study, drug to drug, and disease to disease. And then a very separate issue, how are we going to pay for it? Who is going to pay for it? Are we willing to pay for it? Perhaps then we can make some progress.

[End of Miller’s blog]

For all those who are testifying next week: Good luck! And thank you for stepping up and speaking out.


6 thoughts on “Better Get Your Avastin Gameface On: Patients to Testify Next Week

  1. FAMEDS says:

    Thank you so much for writing this post Katherine and bringing awareness to the urgent cause and the FDA Avastin Hearing! For those reading this article, remember America was founded on being the land of the free, yet a committee is choosing that a working medicine cannot be used by those surviving solely on it. please sign and share with your friends and family members our petition:

  2. katherinembc says:

    Dr. Milton R Wolfe writes in this Washington Times opinion piece:

    An anti-cancer drug called Avastin is no silver bullet but it is an innovative treatment that targets the blood supply of tumors. Nothing yet will cure metastatic breast cancer, but Avastin has been shown to extend women’s lives. It’s now a matter of how long and how much it costs. It’s not a cure but it’s a chance for more time – hope for a final Christmas or to see a son’s wedding or the birth of a granddaughter.

    Bureaucrats at the FDA are like the stereotypical aging athlete constantly reliving his high school glory days. To justify its existence, the FDA fondly points back a full five decades to “everybody’s favorite example”: Thalidomide. American kids were spared the heart-breaking birth defects suffered by Europeans because of the FDA’s slow, more deliberate drug approval process. The FDA trumpets from the rooftops these thousands of Thalidomide lives spared a half-century ago but they become deafeningly silent about the millions of lives still being lost to this day by their foot-dragging.,0_

  3. katie says:

    Katherine, I have had some dealings with FAMEDS and have found them to be supporting a very specific political agenda via twitter. When I questioned them about it, they simply said they send automated tweets. Additionally, they accused me of providing false information about Avastin, but when I asked them to elaborate, they did not reply.

    Avastin was conditionally approved because it was shown to delay the growth of tumors by five months. However, it did not slow the growth by even three months in follow-on studies. More importantly, it didn’t extend survival and comes with serious, even lethal side effects.

    The fact remains that if the FDA revokes its approval, it absolutely does not mean that women with MBC will no longer have access to it. A doctor in this “land of the free” will still be able to prescribe it. The issue is whether insurance companies will cover it, so I think that this whole like of debate is misleading.

    While I empathize with the plight of people with MBC, I don’t think that the debate that FAMEDS is fostering is an honest one at all.


    • katherinembc says:

      I can’t address the FAMEDS issue. I have no insights into the association.

      “Serious even lethal side effects?” Have you considered the other option for most of these metastatic breast cancer patients? GH&D. That’s right, Go Home & Die.

      It is further instructive to note that the European equivalent of the FDA didn’t follow the FDA’s lead:

      In contrast to the US decision, the EMA announced that the approved indication for bevacizumab in metastatic breast cancer remains in Europe, but only for use in combination with paclitaxel (as it was in the original study, the E2100 trial, that led to the original approval.)

      Other combinations, such as with docetaxel or capecitabine, are not approved. These combinations were tested in the Avado and Ribbon-1 trials, and they showed much less benefit. In fact, some of these new data “add uncertainty about the effect on overall survival and a detrimental effect on overall survival cannot be excluded,” the EMA said.

      However, for the combination of bevacizumab and paclitaxel that remains approved, the benefits continue to outweigh the risks, the agency said. “The available data have convincingly shown to prolong progression-free survival of breast cancer patients without negative effect on the overall survival.”

      This contrasts with the view of the FDA, and several journalists at the briefing asked why different conclusions were drawn by the 2 agencies on the basis of the same data. Dr. Pazdur said the FDA can only explain its own decision and cannot comment on action taken by the EMA.

  4. katie says:

    Again, Katherine, the FDA revoking its approval does NOT mean anyone has to stop taking it, only that insurance companies will likely stop covering it. Doctors can still prescribe it. Why not take issue with insurance companies who choose to revoke coverage of it or Roche itself for charging almost $100k per year? Or for not developing an effective drug?

    I certainly never said go home and die and to suggest that I did is pretty insulting. I know a patient with MBC is eventually going to die, but the blood clots caused by this drug can kill them sooner. That’s ok?

  5. katherinembc says:

    Let’s agree to disagree.

    We will hear from the actual metastatic breast cancer patients themselves at the hearing. Let them have their say.

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