Gilteritinib improves outcomes in AML

Patients with acute myeloid leukaemia (AML) who fail to respond to, or relapse after chemotherapy often have dismal outcomes. Now, data from the phase III ADMIRAL trial confirm the efficacy of the FLT3 inhibitor gilteritinib in patients with activating FLT3 mutations in this setting.

A total of 371 adult patients with FLT3-mutant AML who either failed to respond to, or had disease relapse following complete remission in response to anthracycline-based induction chemotherapy were randomized (2:1) to receive gilteritinib or investigator’s choice of salvage chemotherapy. The primary end points were overall survival (OS) and percentage of patients with complete remission and full or partial haematological recovery.

After a median follow-up duration of 17.8 months, patients in the gilteritinib group had a median OS of 9.3 months versus 5.6 months in the chemotherapy group (HR 0.64, 95% CI 0.49–0.83; P < 0.001). Furthermore, 34% of patients receiving gilteritinib had complete remission with at least partial haematological recovery versus 15.3% in the chemotherapy group (risk difference 18.6%, 95% CI 9.8–27.4), including complete haematological recovery rates of 21.1% and 10.5%, respectively.

Common treatment-related grade ≥3 adverse events among patients receiving gilteritinib included febrile neutropenia (45.9%), anaemia (40.7%), and thrombocytopenia (22.8%). Patients receiving gilteritinib were more likely to discontinue treatment owing to adverse events than those receiving chemotherapy (15% versus 7.3%) and had a similar risk of treatment-emergent adverse events leading to death (5.7% versus 7.3%). However, when adjusted for the duration of treatment exposure, patients in the gilteritinib arm had fewer adverse events than those in the chemotherapy arm (19.34 versus 42.44 events per patient-year).

These findings confirm the superior efficacy of gilteritinib versus chemotherapy for patients with FLT3-mutant AML.


Original article

  1. Perl, A. E. et al. Gilteritinib or chemotherapy for relapsed or refractory FLT3-mutated AML. N. Engl. J. Med. 381, 1728–1740 (2019)

    CAS  Article  Google Scholar 

Download references

Author information



Corresponding author

Correspondence to Peter Sidaway.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Sidaway, P. Gilteritinib improves outcomes in AML. Nat Rev Clin Oncol 17, 69 (2020). https://doi.org/10.1038/s41571-019-0305-2

Download citation


Sign up for the Nature Briefing newsletter for a daily update on COVID-19 science.
Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing