BCA fighting to keep tdm1 off market

[Carolyns]

Interesting. At last year's annual NBCC I was an attendee. I felt very much alone as a Stage IV warrior. My greatest concerns were different from the majority of attendees. I went to the NBCC Comparative Effectiveness Presentation hosted by Sean Tunis MD.

The concerns that I expressed were in two categories - A). Over half of the chemos that had worked on me to beat back breast cancer were not approved for Breast Cancer. What if there isn't any data that proves / confirms what is already working? B). Trials for heavily pretreated patients like me. How could I get into trials to stay alive when trials wouldn't accept me or were closed? He mentioned expanded access and compassionate care... He also said that groups could be formed to study and gather data so that people like me could get treatment (sounds like what Joe mentioned). This came up when I mentioned that over 100 women had applied and had not made it into a TDM1 trial that filled up quickly.

I was finally able to get into a TDM1 trial but found all of the other options to be straw man options. They sound comforting until you reach for them and find out that in each situation there is are very valid reasons one of the parties that needs to be involved in the solution can't. Everyone feels just awful about this... terrible... but only one dies waiting and hoping.

This is Sean's information and he seemed very informative and nice. As I said during my ramblings he was the featured speaker at the NBCC conference in DC last year so I am assuming that this organization might also be involved in these sorts of issues.

Sean Tunis MD, MSc
Director, Center for Medical Technology Policy
www.cmtpnet.org

This topic makes me ill and scared out of my mind. Carolyn

[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