Genentech receives FDA Refuse to File Letter for T-DM1

[ElaineM]

Can we start up some kind of petition or letter writing campaign? Does anyone know the correct contacts we can send something to?

[hutchibk]

We need to consult with Dr. Slamon and possibly the Genentech folks how to proceed with an ENORMOUS, LOUD, COHESIVE voice. The triple negative Avastin supporters got a gazillion supporters around their cause recently with a petition for all to sign as one way to speak up. If anyone knows how to coordinate this type of effort, please pipe in!

[sarah]

Hello all,
this seems to be of MAJOR importance to all HER people and we need to mobilize. I'm read to write, etc whomever you find out we should. Nancy, Brenda, chrisy, etc yes who decides this? HER2 isn't like other bc just as inflammable isn't. So Avastin wasn't the miracle drug we all hoped for but for cancer patients time isn't always on their side so isn't it better to try then not??? This isn't a diet pill or some other possible drug where time is less important. With cancer, days count. Maybe the drug companies could be given some leeway in giving out the drug really cheaply for a couple of years before it's got a gold star approval that way patients have the chance to live, drug companies to see if something works and the FDA a chance to see if it really works. Certain diseases just don't have time to wait and cancer falls into that category.
health and happiness
sarah

[Jackie07]

I wondered if this decision has anything to do with the recent pull-back of the trial of Avastin for breast cancer. The FDA is probably trying to avoid repeating the potential mistake of fast tracking for T-DM1.

The sad part is that we've seen so many successful cases posted on this Board from those who had participated in the T-DM1 trial. So many of us are waiting for the approval on January 1, 2011. Unless expanded access is available to all who wants it, this ruling really doesn't make any sense.

[schoonder]

It appears that FDA rules and regulations haven’t kept pace with and thus failed to account for significant changes in how medical scientists today attempt to develop subsets of new drugs that in large part are based on structural composition and specific characteristics of disease, i.e. targeting and killing off just the diseased components without adversely affecting healthy cells.

For Genentech to have included evaluations in their trial of how other treatment regimens, ineffective and no longer frequently prescribed for HER2+ patients would have fared versus T-DM1 3rd level MBC doesn’t only make any sense, but more so it becomes mind-boggling that FDA used this as excuse to delay this, for many an effective and safe drug, from becoming available to very ill people for at least two additional years. A ruling for patients that have depleted their available options becomes a death sentence. And yes, we are so aware that FDA for critical drugs can overrule the need to issue an RTF even if warranted.

Targeted medicine appears to be a much improved method to treat the disease, more efficacious and so much less debilitating to recipient that government needs to assure that vehicle (new rules and regulations) is in place to expedite these new type of drugs to market place. Streamline this process and strike requirements that trials of targeted drugs are required to conduct comparison tests against gamut of all previously approved medication ( old methodology) for given condition.

[Barbara H.]

I will be seeing my oncologist this Thursday. He was involved with the very first trials with TDM-1, and I will ask his advice about what course of action we should take.
Barbara H.

[Jackie07]

I've just sent an e-mail to the White House www.whitehouse.gov

If we all send an e-mail to the President, I'm sure somebody will pay special attention to the matter - especially the fall election is just around the corner.

[ElaineM]

I love the avatar Brenda !! If the members of this board who benefited from T DM1 can be involved in whatever action we decide to take that would be great !! I am going to go to the FDA website over the weekend and see if there is somebody or a particular department we should contact there. I agree that we need a large unified voice. I definitely would sign any petition we decide to start regarding this issue.
I asked my doctor yesterday. He was not even aware of the latest news. Good thing I e-mailed him a copy of one of the press releases earlier in the day, so I just told him to read his e-mail.

[Rich66]

Another take

[ElaineM]

This was also discussed at
http://bcmets.org/articles/130721
and
www.ibcsupport.org

[tricia keegan]

I noticed two ladies on the bc.org site began the petition for avastin to remain and it did get quite a media coverage. Maybe we shoud look at something similar???

Thankfully I don't need to avail of this treatment as yet but would be happy to sign up in support for those that do!

Tricia x

[Darlene Denise]

The Avastin petition was organized by a forum member on another site using thepetitionsite.com.

[Jackie07]

A comment by a physician appeared on CureToday:

http://curetoday.com/index.cfm/fusea...many-questions