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
Gilteritinib receives positive recommendation from EMA CHMP for the treatment of FLT3-mutated AML
Featured:
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended that gilteritinib is granted marketing authorization in Europe for the treatment of FLT3-mutated relapsed/refractory (R/R) acute myeloid leukemia (AML).1
Gilteritinib was previously approved for use in the United States (US) by the US Food and Drug Administration (FDA) in November 2018.2 The EMA CHMP undertook this review as part of the accelerated assessment procedure, designed for therapies of major public health interest.1
The approvals are based on the results of the phase III ADMIRAL study (NCT02421939), which is a randomized trial comparing the use of gilteritinib (120mg/day) to salvage chemotherapy (SC) in patients with FLT3-mutated R/R AML. In total, 138 patients were treated with gilteritinib or SC, with gilteritinib administered until unacceptable toxicity or lack of clinical benefit.2
Interim analysis from the study, with a median follow-up of 4.6 months, showed:2
- Complete response (CR) / CR with partial hematologic recovery (CRh): 21% (n= 29)
- Within any 56-day baseline period:
- Of the 106 patients reliant on red blood cell (RBC) and/or platelet transfusions at baseline, 33 became independent of RBC/platelet transfusions
- Of the 32 patients who were independent of both RBC and platelet transfusions at baseline, 17 remained independent
- Most common adverse events (AEs) in ≥20% of patients:
- Myalgia/arthralgia
- Transaminase increase
- Fatigue/malaise
- Fever
- Noninfectious diarrhea
- Dyspnea
- Edema
- Rash
- Pneumonia
- Stomatitis
- Cough
- Headache
- Hypotension
- Dizziness
- Vomiting
Expert Opinion
Alexander PerlReferences