Gen 1 CarT either cured you or killed you. It came with an accelerated approval with a warning on its box of potential adverse events. This was allowed as the cohort of arms it treated had no other choice. No other treatment had or worked for them. Now, after they have been in use for a while, they are finding some complications that may be related back to previous CarT treatment. The FDA is revisiting this.
This is where Gen 3 CarT is different. They are designed to work better and be safer. There is every chance, if safety remains good with this cd17 drug, that the warning would not be required.
If you get time, have a look at how many arms were dosed for the approval of these first CarT drugs. When there is an unmet need the FDA moves quickly. As those patients have no other chance.
There will be a market for CarT drugs as the cohort they are aimed at have no other choice!
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