If probability of improved patient outcomes is achieved then FDA will often grant approval, even though the Complete Response might seem low.
gilteritinib was approved based on a 21% Complete Response. Learnt that at an AGM for RAC.
https://www.fda.gov/drugs/fda-appro...ry-acute-myeloid-leukemia-aml-flt3-mutatation
It's all about improvement of the probability of survival. If there is an improvement in probability of survival then expect FDA approval.
Ann: Appendix 4C - quarterly, page-85
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