>>is it at all possible for Ariad to request that the black box label be modified?
Nope. That will have to wait for EPIC, and even then the FDA will be very cautious on removing a black box. The system has hysteresis - once you have it, it's very hard to have it removed. I'm not sure I know of any case where this was done, but iclusig could be different because of the accelerated approval issues. (There have been cases I know of where a boxed warning has been weakened, so as to not require monthly testing for example).
They don't yet have any 2nd line data, so the EMA is within its rights to wait. The FDA was more progressive here, going on the science as well as the data.
Peter
