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