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
Withdrawal of European Marketing Association application for ivosidenib for patients with R/R IDH1-mutated AML
On October 16, 2020, the European Marketing Association application for ivosidenib for adult patients with relapsed/refractory (R/R) IDH1-mutated acute myeloid leukemia (AML) was withdrawn. This decision was based on the European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) assessment that the data from the single-arm, uncontrolled phase I study in the R/R AML setting (NCT02074839) did not sufficiently support a positive benefit–risk balance.1
Complete remission or complete remission with partial hematologic recovery was 30.4%, with a median duration of response of 8.2 months. The overall response rate was 41.6%, with a median duration of response of 6.5 months. Treatment-related adverse events of Grade ≥ 3 included prolongation of the QT interval (7.8%), IDH differentiation syndrome (3.9%), anemia (2.2%), thrombocytopenia (3.4%), and leukocytosis (1.7%).2
Find out more about this trial and the FDA approval here. The phase III studies of ivosidenib treatment for newly diagnosed AML, AGILE (NCT03173248) and HOVON150/AMLSG29 (NCT03839771), remain ongoing.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
Your opinion matters
Approximately what proportion of your patients with FLT3-mutations also have NPM1 and DNMT3A co-mutations?