PMID- 32940858 OWN - NLM STAT- MEDLINE DCOM- 20211101 LR - 20211101 IS - 1776-260X (Electronic) IS - 1776-2596 (Linking) VI - 15 IP - 5 DP - 2020 Oct TI - Gilteritinib: A Review in Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukaemia. PG - 681-689 LID - 10.1007/s11523-020-00749-3 [doi] AB - Gilteritinib (Xospata((R))), a next-generation tyrosine kinase inhibitor (TKI), is approved in several countries/regions worldwide for the treatment of relapsed or refractory acute myeloid leukaemia (AML) in adults with FMS-like tyrosine kinase 3 (FLT3) mutations. In this patient population, oral gilteritinib significantly improved overall survival (OS) and the response rate for complete remission with full or partial haematological recovery compared with salvage chemotherapy in the phase III ADMIRAL trial. In an integrated safety analysis of patients with relapsed or refractory AML, the most commonly reported grade >/= 3 treatment-related adverse events (AEs) in gilteritinib recipients included anaemia, febrile neutropenia and thrombocytopenia. Clinically relevant AEs of special interest (AESIs) with gilteritinib therapy included differentiation syndrome, posterior reversible encephalopathy syndrome, QT interval prolongation and pancreatitis. AEs, including AESIs, were generally manageable with dose reduction, interruption or discontinuation. All patients of reproductive potential should use contraception during gilteritinib treatment due to the risk of embryo-foetal toxicity. Given its convenient oral regimen, along with the poor prognosis and paucity of treatment options for adults with relapsed or refractory FLT3-mutated AML, gilteritinib represents a valuable first-line targeted monotherapy in these patients. FAU - Kang, Connie AU - Kang C AD - Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. demail@springer.com. FAU - Blair, Hannah A AU - Blair HA AD - Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. LA - eng PT - Journal Article PT - Review PL - France TA - Target Oncol JT - Targeted oncology JID - 101270595 RN - 0 (Aniline Compounds) RN - 0 (Pyrazines) RN - 0 (gilteritinib) SB - IM MH - Aniline Compounds/pharmacology/*therapeutic use MH - Female MH - Humans MH - Leukemia, Myeloid, Acute/*drug therapy/pathology MH - Male MH - Middle Aged MH - Pyrazines/pharmacology/*therapeutic use EDAT- 2020/09/18 06:00 MHDA- 2021/11/03 06:00 CRDT- 2020/09/17 12:17 PHST- 2020/09/18 06:00 [pubmed] PHST- 2021/11/03 06:00 [medline] PHST- 2020/09/17 12:17 [entrez] AID - 10.1007/s11523-020-00749-3 [pii] AID - 10.1007/s11523-020-00749-3 [doi] PST - ppublish SO - Target Oncol. 2020 Oct;15(5):681-689. doi: 10.1007/s11523-020-00749-3.