The aml Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the aml Hub cannot guarantee the accuracy of translated content. The aml and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The AML Hub is an independent medical education platform, sponsored by Astellas, Daiichi Sankyo, Johnson & Johnson, Kura Oncology and Syndax, and has been supported through educational grants from Bristol Myers Squibb and the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View aml content recommended for you
Olutasidenib granted FDA approval for patients with IDH1-mutated R/R AML
On December 1, 2022, olutasidenib, an oral, small molecule, IDH1 inhibitor was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with IDH1-mutated relapsed or refractory (R/R) acute myeloid leukemia (AML).1
This approval is based on results from a phase II study (NCT02719574) that has previously been reported on by the AML Hub. Briefly, the study included 147 adult patients with R/R AML who were treated with oral olutasidenib at a dose of 150 mg, twice daily.1
- A total of 35% of patients achieved either complete remission (CR) or complete remission with partial hematological recovery (CRh).1
- The median time to CR+CRh was 1.9 months and the median duration of CR+CRh was 25.9 months.1
- In 86 patients who were red blood cell and/or platelet dependent at baseline, 34% became transfusion independent.1
- In 61 patients who were transfusion independent at baseline, 64% remained transfusion independent during any 56-day post-baseline period.1
Olutasidenib was well tolerated with an acceptable safety profile. The most common adverse reactions included nausea, fatigue/malaise, arthralgia, constipation, leukocytosis, dyspnea, fever, rash, mucositis, diarrhea, and transaminitis. Olutasidenib has a boxed warning regarding the risk of differentiation syndrome.1
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content
