All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.
The AML Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
Mutation testing in AML:
What you need to know
with Charles Craddock, Ralph Hills, and Gail Roboz
Wednesday, April 23, 2025
17:30-18:30 BST
This independent educational activity is supported by Thermo Fisher Scientific. All content is developed independently by the faculty. The funder is allowed no influence on the content.
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 Hub 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.
Ivosidenib granted approval by the European Commission for the treatment of adult patients with IDH1-mutated AML
Bookmark this article
On May 10, 2023, oral ivosidenib, a small molecular isocitrate dehydrogenase-1 (IDH1) inhibitor, was approved by the European commission in combination with azacitidine for the treatment of adult patients with newly diagnosed (ND) acute myeloid leukemia (AML) with an IDH1R132 mutation who are ineligible for standard induction chemotherapy.1
Following key data from the phase III AGILE trial (NCT03173248), ivosidenib in combination with azacitidine is already approved by the U.S Food and Drug Administration (FDA) for the treatment of IDH1-mutated AML in adult patients ≥75 years old and for those with comorbidities precluding the use of standard intensive induction chemotherapy.2 Results demonstrated a favorable safety profile, improved event-free survival (hazard ratio [HR], 0.33; 95% confidence interval [CI], 0.16, 0.69), and improved overall survival (HR, 0.44; 95% CI, 0.27, 0.73) in patients with IDH1-mutated ND AML who received ivosidenib plus azacitidine, compared with those who received azacitidine plus placebo.1
Ivosidenib is also FDA approved as a monotherapy in patients with relapsed/refractory or ND IDH1-mutated AML3, and in patients with locally advanced or metastatic IDH1-mutated cholangiocarcinoma who have been previous treated.1,3
- Servier receives European commission approval of Tibsovo® (ivosidenib tablets) in IDH1-mutated acute myeloid leukemia and IDH1-mutated cholangiocarcinoma. https://mma.prnewswire.com/media/2074010/Servier_Tibsovo_EC_Approval.pdf. Published May 10, 2023. Accessed May 11, 2023.
- Ivosidenib in combination with azacytidine receives FDA approval for the treatment of IDH1-mutated newly diagnosed AML. https://aml-hub.com/medical-information/ivosidenib-in-combination-with-azacitidine-receives-fda-approval-for-the-treatment-of-idh1-mutated-newly-diagnosed-aml. Published May 31, 2022. Accessed May 11, 2023.
- TIBSOVO®. Prescribing information. Servier. Accessed May 11, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211192_s008lbl.pdf
Your opinion matters
3 votes - 21 days left ...
Newsletter
Subscribe to get the best content related to AML delivered to your inbox