Ann: Impressive Bisantrene Phase 2 AML Clinical Results, page-95

what it takes to get FDA approval for R/R AML. Perhaps we see Venetoclax combo with accelerated approval with EMD surrogate endpoint. Approval of the back of P2.

March 2023 https://ashpublications.org/ashclinicalnews/news/6956/FDA-Approves-Treatment-for-R-R-AML#:~:text=The%20U.S.%20Food%20and%20Drug,%2C%20an%20FDA%2Dapproved%20test.

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March 2023 Latest & Greatest

The U.S. Food and Drug Administration (FDA) approved olutasidenib for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible IDH1 mutation in adult patients. The mutation must be detected by the Abbott RealTime IDH1 Assay, an FDA-approved test.

Approval was based on the results of an open-label, single-arm, multicenter trial, dubbed Study 2102-HEM-101. Of 147 patients, the rate of complete remission (CR) plus CR with partial hematologic recovery (CRh) was 35% with a median duration of 25.9 months. Of the 35% who achieved CR + CRh, 92% achieved CR with a median duration of response of 28.1 months.