[chrisy]

Roche's number one priority is to get this drug approved. The barriers dropped in front of this process have been incredible - unconscionable some might say. The decision to close the EAP was a difficult and painful one (certainly for patients!) but was made in the interest of getting access for everyone via FDA approval.

That approach has manifested itself in the design of trials with 2/3 randomization to TDM1, and the opening of multiple large phase 3 trials.

One of the most perverse consequences of the FDA requirement to provide overall survival data is that it basically precludes anyone who has been in a TDM1 trial in a control arm from being allowed to get it later, say in an EAP. If everyone in a control arm (no TDM1) and had progression then subsequently got TDM1 and it worked, they would never be able to show a survival benefit and thus gain approval.

One very cool thing is the pertuzumab/TDM1 trials. In those, you may or may not get pertuzumab, but you definitely get TDM1, so a very likely winner in either case!