[chrisy]

Some additional, bottom line info not clear from the "release" above and not ALL bad news:

1. Patients who ENTER screening for a T-PAS (EAP) before September 6 will be able to enter the T-PAS if they qualify. So if you're on the fence, my advice is get the ball rolling now, there is still a chance to get in.

2. Gene is still working on amendments to the T-PAS so that patients who are IN one of the EAP studies can roll over into an extension study or another study and continue to have access to T-DM1 if they are stable and tolerating treatment with T-DM1. The effect of this is there will be about double the number of trial sites, thus reducing the travel burden especially for Boston/NY and Northwest area patients.

3. The new 3rd line MBC study (TH3RESA) which will open in August/September has the same "inclusion" criteria as the T-PAS did (prior anthracycline, taxane, capecitabine and herceptin and tykerb regimens). The main difference is that this is a randomized study so patients might not be randomized to the T-DM1 arm. BUT it is a 2:1 randomization so you have a 2 in 3 chance instead of 50/50.

Overall my personal opinion is that I do understand that the requirement to show OS (overall survival) benefit complicates efforts to give patients access - and that the main goal is to not jeopardize the ultimate approval of TDM1. For me, the finger points to the FDA as the barrier to access although I know there are others who disagree.

However I am exceedingly disappointed and frustrated that this means additional delays and reduced access for those who need it NOW, not in another 3 years!