|YM by earnie:|
306 SPA 7-Jul-11 09:36 am
Right before ASCO, EXEL had its end of phase 2 meeting with FDA. Included in their description of this meeting was the statement that FDA senior management was well represented at this meeting. FDA followers know that in the Oncology Division, there is very little power sharing and most important decisions come directly from Dr. Pazdur. I cannot speak for EXEL, but I suspect that their statement was codespeak that Dr. Pazdur was in attendance.
Throughout ASCO and the subsequent presentations EXEL has described the meeting as productive and said that FDA input at that meeting gave them a clear path going forward to craft an SPA for the 306 trial. They did not say that the FDA had accepted or embraced a bone scan resolution endpoint as an approvable criteria. They did say that FDA comments were incorporated into the submitted protocol. That is not quite the same thing as saying that all of the FDA's comments were incorporated.
Make no mistake, this is a very high stakes game for EXEL. The sample size is large enough now to say unequivocally, the bone scan resolution phenomenon is real and unique. If a primary endpoint has a significant bone scan input, treatment arm efficacy will dwarf that of any imaginable drug treatment chosen as the control. Granting an SPA with a bone scan input that is a comparative criteria for Cabo vs control may be tantamount to approving a trial with a foregone conclusion.
The devil could be in the details. The proposed 306 trial is described as employing "a combined endpoint of pain reduction and bone scan response." Does this mean that Cabo has to show superiority by both criteria separately or the single endpoint is made up of patients who show both a pain reduction and bone scan improvement? It may be that the drug approval is based on the pain reduction side and the bone scan response part is included so as to give a broader label description. Hopefully, when the SPA is finally agreed to, EXEL will provide enough clarity to be able to understand the exact makeup of the combined primary endpoint.