azacitidine
The results of the trial were presented during the 2022 ESMO Congress by Chunkang Chang, MD, PhD.
The researchers analyzed data from previously untreated adult patients with low- or intermediate-risk MDS.
The analysis results have clinical implications, as venetoclax-based regimens are the standard of care for patients.
Investigators retrospectively identified patients with PTCL who were treated with romidepsin plus subcutaneous azacitidine.
A retrospective study showed that response rate and survival outcome are still modest for high-risk patients.
The study analyzed 70 transplant-ineligible patients with high-risk MDS and MDS/AML with less than 30% of myeloblasts.
The approval was based on data from a trial that randomized patients with newly-diagnosed IDH1-mutated AML.
The FDA approval was based on data from the AZA-JMML trial, which observed half of patients reach confirmed responses.
Event-free survival was longer in patients treated with ivosidenib plus azacitidine compared with placebo plus azacitidine.
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