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Molecular Profile FLT3 exon 14 ins
Therapy Crenolanib
Indication/Tumor Type acute myeloid leukemia
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FLT3 exon 14 ins acute myeloid leukemia sensitive Crenolanib Preclinical - Cell culture Actionable In a preclinical study, Crenolanib inhibited Flt3 phosphorylation and growth of acute myeloid leukemia cell lines harboring FLT3 exon 14 insertions (ITD) in culture (PMID: 31309543). 31309543
FLT3 exon 14 ins acute myeloid leukemia sensitive Crenolanib Phase II Actionable In a Phase II trial, treatment with Crenolanib (CP-868596) and chemotherapy demonstrated efficacy in patients with newly diagnosed acute myeloid leukemia harboring FLT3-ITD and/or FLT3 tyrosine kinase domain (exons 14-23) mutations, with an overall response rate of 86% (38/86, 34 complete remission and 4 complete remission with incomplete recovery), median event-free survival of 44.7 months, and median overall survival that was not reached (PMID: 38324741; NCT02283177). 38324741
FLT3 exon 14 ins acute myeloid leukemia sensitive Crenolanib Preclinical - Patient cell culture Actionable In a preclinical study, FLT3-ITD mutations correlated with sensitivity to Crenolanib in patient-derived acute myeloid leukemia samples in an ex vivo assay (PMID: 30333627). 30333627
FLT3 exon 14 ins acute myeloid leukemia sensitive Crenolanib Phase I Actionable In a Phase I trial, Crenolanib treatment resulted in an overall survival (OS) of 238 days in AML patients harboring FLT3 exon 14 insertions (ITD) that received no prior therapy, and an OS of 158 days in those progressed on TKIs (J Clin Oncol 34, 2016 (suppl; abstr 7008)). detail...
PubMed Id Reference Title Details
Crenolanib besylate, a type I pan-FLT3 inhibitor, to demonstrate clinical activity in multiply relapsed FLT3-ITD and D835 AML. Full reference...
(30333627) Functional genomic landscape of acute myeloid leukaemia. Full reference...
(31309543) Comparison of effects of midostaurin, crenolanib, quizartinib, gilteritinib, sorafenib and BLU-285 on oncogenic mutants of KIT, CBL and FLT3 in haematological malignancies. Full reference...
(38324741) Crenolanib and Intensive Chemotherapy in Adults With Newly Diagnosed FLT3-Mutated AML. Full reference...