Ariad Pharmaceuticals Inc fka ARIA

[smeagol]

not oncology directly, but pharma world I know.

you ask difficult questions, but I try:

I think you cannot compare Trastuzumab situation with a potential Pona filing with abbreviated, great data.
First, I believe that the FDA's decision was influenced by the parallel and ongoing discussion on Avastin (you know, accelerated approval, and then very disappointing follow-up data and negative ODAC opinion) - should not influence a decision, but surely did.

Second, FDA stated that "T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population." I read an article discussing this issue, and it seems that this argument was stretched, but nevertheless true.
Surely FDA should have approved Trastuzumab, but they get more cautious every day....

Ponatinib, on the other side, is in a quite different situation - I don't have to explain this to you.

regarding resistance and mutation - I'm quite sure that this will happen, but id does not change the fact (as it looks right now) that it happens later, and for less patients.

take care