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Gilteritinib-induced severe immune-related enteritis: a possible case report
Pan Luo1,2, Huiying Qiu3, Yushan Yang1,4
1Department of Clinical Pharmacy, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.
Abstract:
Gilteritinib is currently approved in China for relapsed/refractory FLT3-mutated acute myeloid leukemia, and it is very important to monitor and report its adverse drug reaction (ADR) after post-marketing. This case report describes a patient who was diagnosed with acute myeloid leukemia harboring FLT3 mutations and developed a severe suspected immune-related enteritis during treatment with gilteritinib for maintenance therapy following allo-hematopoietic stem cell transplantation. According to the Naranjo probability scale, gilteritinib was defined as a 'possible' cause of ADR. Another suspicious inducement, graft-versus-host disease, can not be eluted and might represent a limitation in this case. To the best of our knowledge, this is the first report on gilteritinib-induced severe enteritis and will help physicians to keep vigilant, and detect and deal with time for possible ADR.
Insights
This case report details a severe immune-related enteritis possibly caused by gilteritinib in a patient with FLT3-mutated acute myeloid leukemia. Early detection of this adverse drug reaction is crucial for patient management.
Area of Science:
- Oncology
- Pharmacology
- Gastroenterology
Background:
- Gilteritinib is approved in China for FLT3-mutated acute myeloid leukemia (AML).
- Post-marketing surveillance for adverse drug reactions (ADRs) of gilteritinib is essential.
- Immune-related adverse events are a known concern with targeted cancer therapies.

