The first CarT drug was approved after a trial with 63 patients. It had a 90% response rate (70% CR 20% remission). It also had an 80% adverse event rate. Some of these adverse events caused death. So a warning was included with the approval where patients had to be rold they had a great chance of getting better with the treatment, but also a chance of death because of it.
https://aacrjournals.org/cancerdiscovery/article/7/10/OF1/6073/First-Ever-CAR-T-cell-Therapy-Approved-in-U-S
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-first-fda-approval-car-t-cell-immunotherapy
https://pmc.ncbi.nlm.nih.gov/articles/PMC10225594/
Now PTX100 isnt a CarT. its Kras. But the approval process is the same. PTX100 has a much better safety profile.
PTX might not need a large patient cohort for approval if it can produce good data.
The first CarT drug was approved after a trial with 63 patients....
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