Well the way I see it, is the FDA were determined to grant these approvals despite the high trial death rate. It really didn't matter what phase it was in.
Single arm open label P2's are a recipe for uncertain efficacy, and very uncertain safety.
As we have seen with the ICI's.
I guess you could say that these Car-T's are a bit of a special case, and that is certainly how the FDA treated them.
I'd have to check it out, but for the approved indications, patients reliably fail first line and then have a short survival expectation.
The 'foot in the door' principle applies. NSCLC is the best example of approvals moving from third line, second line to first line.
But you're right that Car-T approvals for any solid cancer won't come for at least 2-3 years, and even then, Car-T treatments won't go straight to first line.
By which time better, safer, cheaper alternatives will be on the way.
Though the world won't wait forever.
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