Carfilzomib:
I don't disagree that there is a risk here and am accordingly prepared. The one small fact that gives me comfort is that the FDA is very familiar with accelerated approval in myeloma. Their strategy in this indication has worked really well for them in the past, so I think there is an intangible that works in ONXX's favour.
At the same time, I have to shake my head at Weber's biggest red flag: The Trial Also Enrolled Patients Who Were Intolerant of Velcade, But Did Not Truly Fail.
Well, technically yes, if you can't tolerate Velcade, did not take it, and moved onto carfilzomib, you're not Velcade refractory. But is this really relevant? As far as I'm concerned, patients refractory to Velcade are just as eligible, clinically, for carfilzomib as patients who can't take / tolerate Velcade.
Dumb point by Weber.
