BCA fighting to keep tdm1 off market

[Joe]

I do not feel that one letter from one breast cancer organization will sway Genentech from applying for approval of T-DM1 or the FDA from approving the application.

The application will probably cover just those stage IV patients who are still progressing after treatment with Herceptin, Tykerb and other drugs.

Genentech currently has a phase III trial underway since January 2009. The trial design calls for 580 patients. Considering the success of the Phase II trials, I would assume tha the trial will complete recruitment within the next few months. The final data has an estimated completion date of August 2013 and will probably use that data for their formal FDA application . There is no reason why patients that NEED the drug now should needlessly die. As someone else stated, the side effect of not having access to T-DM1 is certain death.

I cannot understand why BCA would take a stand on an application not yet submitted as no one has any idea what the application will cover.

If it only covers those patients who ran out of options...then I support it.

One only has to do a search on "Irene from Tampa" from September 1, 2009 to her death would understand why this approval is needed. I personally spent hours on the phone with Genentech and others advocating for her to receive T-DM1 to no avail due to FDA requirements.

Warmest Regards
Joe

[schoonder]

Joe, maybe time spend on the phone with Genentech, trying to get Irene back on t-dm1 medication wasn't all for naught. Roche, today during a conference call announced that they will file this year for t-dm1 3L approval based on strong data results seen from the phaseII trial.
The FDA, according to Pascal Soriot, head of the Basel, Switzerland -based company's drug unit: “They accepted the data and with great enthusiasm.”

[hutchibk]

http://her2support.org/vbulletin/showthread.php?t=44689

Joe's update today.

[Joan M]

I had the opposite experience with trying to get into a TDM1 trial: I hadn't taken any chemos for advanced bc and therefore was not eligible because Genentech kept ratcheting up the ante, pitting the drug against more and more proven agents. The trial was the only option I considered in place of having a lung radiofrequency ablation for the tumor recurrence. It was either the RFA or the trial.

The quicker the approval, the better. Top oncs at research hospitals can work on skipping steps and getting approval when a drug shows a lot of promise.

Joan

['lizbeth]

I think that stage IV cancer fighters should be exempted from the current system and with a legal waiver to the developing comany be allowed access to drugs that might improve and prolong their life.

Why do we allow others to die to "protect the data". Have a group that is exempt from the data and make compassionate use more accessible.

I am deeply dismayed by the recent denial of fast tracking, and wonder if your organization is a cover for insurance company interests that would rather we suffer and die on the old awful chemos that have access to promising new, targeted, more expensive drugs......

[ElaineM]

I think we have some good contacts if we want to start a petition/writing campaign. Maybe we should flood their inboxes with mail. Maybe they need to hear from a few hundred or a few thousand actual patients/consumers who are directly affected by their decisions.

[chrisy]

Unregistered:
That would be a question to ask them. Link to their website is
http://bcaction.org/index.php?page=about-bca
Check out their website and see what they are about.

My personal opinion, having met/heard representatives from this group on several occasions, is that they are very passionate about what they believe and have a strong activist and social justice orientation. They think cancer sucks (as do we) but have a very different agenda about how to deal with it. I especially have very different experiences and beliefs with respect to if the pharmaceutical industry is friend or foe.

I disagree with them on a lot of issues and priorities, but I do not see them as shills for the insurance company.

From their website description of "what we do"
1. Advocates for policy changes in three priority areas:
- Treatment by shifting the balance of power at the FDA away from the pharmaceutical industry and towards the public interest while advocating for more effective and less toxic treatments.
- Environment by decreasing involuntary environmental exposures that put people at risk for breast cancer.
- Inequities by creating awareness that it is not just genes, but social injustices - political, economic, and racial inequities - that lead to disparities in breast cancer outcomes.
2. Provides information to anyone who needs it via newsletters, Web sites, e-alerts, and a toll-free number.
3. Organizes people to do something besides worry.

Their world view confuses me. For example their actions and position re TDM1- in my view fast approval of TDM1 serves the public interest because it is a more effective and less toxic treatment. To have the FDA refuse to file accelerated approval because they felt that regardless of Her2 status, trial subjects should have had more failures of non-targeted chemos is not a victory under either of these "priorities".

What I would say in their favor and would like to learn from that organization and others is they how to mobilize people and effect change. I think they have things to teach us in that realm. Of course, the first political changes I would want to influence would be to push the FDA in the OTHER direction.

They have a formidable organization and website, and although Her2support has a different mission (and Joe and Christine have not wished to have political discussions "in their living room"), as individuals we could be better armed to handle those issues.

Here's a tip from their website on how to write letters to the editor:
http://bcaction.org/index.php?page=t...-to-the-editor

As an FYI, I have never seen a double blind Phase III for a cancer drug. In general, the Phase III studies are "standard of care" or the drugs currently used in treatment compared to "standard of care" plus your drug. In Stage IV BC patients, a Phase III trial could be designed so that "standard of care" includes Tykerb/Herceptin plus a chemo, for example, vs TDM-1. It is unethical to run a placebo controlled trial in patients that would surely progress without some form of treatment. What becomes a problem is designing a trial that includes drugs that many patients have not already received in some combination vs the new drug. It's not as easy as it sounds since the combination you choose for comparison could go out of favor during the trial and the trial then needs to be amended. Meanwhile, you still need to show statistical significance and fulfill other FDA requirements or risk not getting your drug approved.

Another guest.

[chrisy]

Guest -
There can be a double blind phase III study for a cancer, or any drug but you are correct that there would not be a placebo-controlled trial in this setting - it would always be in comparison to "standard of care".

Double blind just means that neither the patient or people giving the drugs know which drug is being given, so this is supposed to eliminate the placebo effect - where belief a therapy works/won't work actually impacts the results.

You make an excellent point about the moving target on "standard of care", and the challenges of designing trials with the appropriate comparisons. To include Ixempra for as a "you have to have tried that first" doesn't make sense to me as it has only just recently been approved itself.

Conversely, requiring MBC patients to have had Taxol AND Anthracycline is archaic as the first line MBC combination of choice now is herceptin and a taxane, not anthracycline.

Agreed, you have to show statistical significance either way but with the variety of therapies and the velocity of new developments, the FDA and drug co's need to do a MUCH better job of assessing new therapies more quickly.

Just as the "standard of care" changes, the "standards of approval" need to keep up with the science. That doesn't mean lowering standards, but as the science and oncology community moves more to personalized therapy (based on the individual's cancer biology), the old system of testing everything on everyone just doesn't cut it.

Just my humble opinion since I'm neither a scientist or an oncologist. Just a dumb Stage IV lab rat hoping for a cure...soon.

[Soccermom]

Gotta wonder what BCA thinks of the ISPY trials????

MUST SEE THIS! very hopeful


please watch this piece,I was lucky enough to sit in on (via webcast) and be part of the Q & A for this press conference.

http://vimeo.com/10262851
http://vimeo.com/10262072
http://vimeo.com/10263498
http://vimeo.com/11878324
There are 10 separate videos which are numbered and I posted just a few URL's... I believe this is EXCELLENT news for all

Chrissy,

Thank you for your post, all very good points. I would like to comment that you are not at all a "stupid" Stage IV patient but obviously very knowledgeable and I am right there with you hoping that the companies and the FDA can figure out better ways to get drugs approved. Also, good point SoccerMom regarding the ISPY trials, a real breakthrough in trial design.

Guest again.

[Jackie07]

I went to the BCA site and read some of their 'actions' from the 'Timeline' section http://bcaction.org/index.php?page=timeline:

1993 BCA testifies before the FDA in opposition to resuming the Breast Cancer Prevention Trial, a study of the drug tamoxifen in healthy women, because of reports of deaths from uterine cancer in the trial.

1995 BCA calls for the drug tamoxifen to be added to the list of substances known to the State of California to cause cancer. Despite the objections of Zeneca (the drug’s manufacturer) and then-Governor Pete Wilson, BCA’s argument prevails in 1996

1997 Citing the absence of evidence that routine mammography screening reduces breast cancer deaths for women aged 40 to 49—and noting the risks of mammography screening, including radiation exposure and the risk of false positives and false negatives—BCA publicly opposes the call by the National Cancer Institute, the American Cancer Society, and others for routine screening among women in this age group.


1997 BCA revises its mission statement and becomes the first national breast cancer organization to adopt a policy explicitly prohibiting accepting financial support from corporations, such as pharmaceutical companies and corporate polluters, that profit from or contribute to the cancer epidemic.

1999 Over the objections of other breast cancer organizations and the American Cancer Society, BCA successfully calls for the National Cancer Institute to promptly release the results of clinical trials testing high-dose chemotherapy/autologous bone marrow transplants for breast cancer.

BCA leads the call to guarantee that poor and uninsured women screened for breast cancer at state expense receive prompt access to quality treatment at state expense.

2002 BCA’s web site wins the People’s Choice Webby Award for best health web site.
BCA jointly releases the first edition of the report “State of the Evidence: What is the Connection Between the Enivronment and Breast Cancer?”

2003 BCA presents testimony to the FDA opposing attempts to reintroduce silicone breast implants, citing numerous safety concerns.
BCA launches an online aromatase inhibitor survey to collect information on the side-effects of this new form of breast cancer treatment.

2007 Asserts a unique perspective, focusing on cost and effectiveness, in opposition to approval of Avastin as a treatment for breast cancer.
Successfully argues for cancellation of STELLAR Trial, maintaining that pills for prevention always results in disease substitution.
Publishes initial Aromatase Inhibitor Side-effects Survey results

2008 Successfully advocates for removal of phthalates in cosmetics made by Secret, Arrid and Christian Dior.
Think Before You Pink Critical Questions appear in promotional literature and media statements from Susan G. Komen For The Cure and the American Cancer Society.

2009 Launches Milking Cancer campaign demanding that Eli Lilly stop making rBGH, thus removing it from the world market. Thousands take action in the fist week.
Successfully testifies on behalf of patients at the FDA against the approval of Doxil for metastatic breast cancer.
Joins ACLU in lawsuit against Myriad Genetics for their patents on breast cancer genes BRCA1 and BRCA2.
Dannon follows suit to General Mills and announces plans to go rBGH-free.
In response to consumer demand and BCA’s Think Before You Pink campaign, General Mills announces plans to go rBGH-free.

2010 BCA wins lawsuit against Myriad Genetics by challenging the company’s patents on breast cancer genes, BRCA1 and BRCA2. Patents were ruled invalid by a United States Federal judge on March 29, 2010.
Breast Cancer Action celebrates its 20th anniversary year!
FDA is responsive to BCA's concerns about ESA's, as well as time of FDA informational conference calls
Working on legislation to prohibit patenting of genes, in particular on breast cancer genes BRCA1 and BRCA2
BCA's policy is hailed as a leader in the field of screening and mammography
BCA begins exploratory conversations with Eli Lilly

[Soccermom]

This is the link to the lawsuit as filed by the ACLA and MANY, MANY others. It was NOT "BCA's lawsuit".. multitudes of patient advocacy orgs,patients etc. filed the suit. Joanna Rudnick producer of the documentary,"In the Family" takes Myriad to task in the film..

Funny enough this is an organization (BCA) that has historically been extremely vocal and aggressively AGAINST genetic testing for many years.
Have to wonder EXACTLY what their agenda is ,"methinks thou doth protest too much" ??

(okay forgive me my rant, I'll get off my soapbox now)
http://www.aclu.org/files/pdfs/frees...ppto_uspto.pdf

Hugs to you Jackie!

Spam above!

[StephN]

Took out the spammer.
The above is a good conversation and I wonder where BCA now stands?

[schoonder]

"wonder where BCA now stands"

Hope they're satisfied because Genentech pretty much provided what BCA was looking for. Such as two "large scale" phase III evaluations, one (Marianne) in 1st-line setting and the other (Emilia that's now ~70% enrolled) in 2nd-line setting. Roche also plans to conduct a third phase III trial (T-DM1 vs doctor's choice) and expects 1st patient in (FPI) during 3 Q 2011. Genentech's extension trial in a somewhat limited fashion is still ongoing.

[radiant]

There's no other way to say this: THIS infuriates me. It's wrong, wrong, wrong. There must be something we can do?

- Kim

BCA says that poor and uninsured women are covered under the National Breast and Cervical Cancer screening program. WRONG! Only women who are 40-64 are eligible for the breast cancer screening program and between 40-50 it's up to the provider's discretion.

[hutchibk]

True, Soccermom. It was NOT BCA's lawsuit. It actually was initiated by my friend Genae Girard here in Austin who is a member of my local b/c support group. I was in support of it early on when she would come to me to talk about it, but I backed away to the sidelines big time when she started recruiting the ACLU and BCA as well as other activists to help move it forward. I know it helped her in the long run get the result she wanted, but it felt smarmy at the point that I saw who the others were that were jumping on the train. http://online.wsj.com/article/SB126041358100284931.html