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 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
FDA Fast Track designation granted to devimistat for the treatment of AML
On December 15, 2020, it was announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to devimistat, a lipoate analog, for the treatment of acute myeloid leukemia (AML). The efficacy and safety of devimistat is currently being evaluated in the pivotal phase III ARMADA 2000 trial (NCT03504410) in combination with high dose cytarabine (HiDAC) + mitoxantrone.1-3
Devimistat1,2
- First-in-class lipoate analog that inhibits pyruvate dehydrogenase and alpha-ketoglutarate dehydrogenase and therefore stops the mitochondrial tricarboxylic acid cycle in cancerous cells, leading to cell death2
- Increases the sensitivity to other chemotherapeutic agents, allowing for potential combinations that could reduce the cytotoxicity and other side effects of chemotherapeutics
- Previously received Fast Track designation for the treatment of metastatic pancreatic cancer
- Previously received orphan drug designation by the FDA, for the treatment of AML, myelodysplastic syndromes, peripheral T-cell lymphoma and Burkitt’s lymphoma, pancreatic cancer, and soft tissue sarcoma; and by the European Medicines Agency (EMA) for AML and pancreatic cancer
ARMADA 2000 (NCT03504410)3
- Multicenter, open-label, phase III study of devimistat in combination with HiDAC + mitoxantrone in comparison with HiDAC + mitoxantrone and control combination sub-groups: mitoxantrone, etoposide, and cytarabine (MEC) and fludarabine, cytarabine, and filgrastim (FLAG) in older patients (≥ 50 years) with relapsed/refractory AML
- Start Date: November 12, 2018
- Estimated enrollment: 500
- Primary outcome: Complete remission
- Secondary outcomes: Overall survival, complete remission + complete remission with partial hematologic recovery
The Fast Track designation of this compound, particularly during a pandemic, highlights the need for new treatment options in the relapsed/refractory AML setting.
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