<<Even 10% response rate (accompanied with medical benefit) is something that FDA will consider very seriously.>>
Which part of this you missed or did not got right?
10% + ACCOMPANIED?
As you mentioned correctly, accelerate drug approval method use surrogate end-point as appropriate value for efficacy. At the some time of the approval company need to run large trials with *medical* end point.
So far Erbitux has surrogate end-point in clinical testing. For PII CC they have TTP and one year survival data, but this was without control (it does not have to be placebo, it has to be against standard and/or comparable regime, but randomized) and data are not accurate.
The PIII H&N was doom to fail from start. This is highly aggressive cancer type after chemo failed, so increase in response rate does not always translate in survival benefit.
Erbitux just started larger pivotal trials (combinations regime). Like Iressa and Avista it may generate pure primary end-point results even with good response rate. But, we do not KNOW yet what will be result? And like with Iressa and Avista open-label PII is not right measure for PIII prediction. Only guidance which indication it is worth to try.
So, yes, so far we do not have SOLID evidence that drug work. Only indication where it may work.
You are saying that because luck of the assuring and decent PII data drug DOES NOT (or may not) work.
I am saying that drug MAY work, because of the validated target (someone may said that this is not correct) and mechanism by which drug may have synergy with chemo. However, Erbitux is the weakest anti-EGF candidate so far, imo.
Again, I have no position on IMCL. Never had.
Miljenko |
