re: ARIA
>Geeez, give us some punch, dude.<
The train has left the station!
Uh, but seriously, the results in the T315I mutation bearers look very good to me. The pivotal trial will be separating people with and without this mutation, so I think it is very reasonable to assume that the results in the mutation bearing group will satisfy accelerated approval criteria.
I say this because they're getting 100% major cytogenic response in chronic phase patients with the T315I mutation (88% complete cytogenic). This is the kind of response you get in first line patients without the T315I mutation, let alone patients with the T315I mutation that have moved through multiple rounds of treatment. One can argue that since the other drugs don't work well against this mutation that it may effectively be the first time these patients are really treated with a bcr-abl inhibitor. But that's not any reason whatsoever to disparage the quality of the results.
As for the group as a whole, regardless of T315I mutation status, I think I'd like to wait until the presentation before saying anything.
