Gilteritinib: A Review in Relapsed or Refractory FLT3 -Mutated Acute Myeloid Leukaemia
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ADIS DRUG EVALUATION
Gilteritinib: A Review in Relapsed or Refractory FLT3‑Mutated Acute Myeloid Leukaemia Connie Kang1 · Hannah A. Blair1
© Springer Nature Switzerland AG 2020
Abstract Gilteritinib (Xospata®), 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.
1 Introduction Acute myeloid leukaemia (AML) is one of the most common (≈ 1% of all cancers [1]) forms of acute leukaemia in adults, with a rate of 3.5 (in Europe [2]) or 4.3 (in the USA [3]) cases per 100,000 people per year. AML incidence increases with age (particularly in those aged over 60 years) [4], with a corresponding decrease in the 5-year survival rate (up to 28.7%) [3]. This disease is characterized by driver mutations and epigenetic alterations that lead to its clinical Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.12885569. The manuscript was reviewed by: G.-N. Franke, Medical Department I-Hematology and Cell Therapy, University of Leipzig Medical Center, Leipzig, Germany; R. A. Larson Department of Medicine, University of Chicago Medicine, Chicago, IL, USA; C. Ustun Department of Medicine, Division of Hematology, Oncology, Cell Therapy, Rush University, Chicago, IL, USA. * Connie Kang [email protected] 1
Springer Nature, Mairangi Bay, Private Bag 65901, Auckland 0754, New Zealand
Gilteritinib: clinical considerations in relapsed or refractory FLT3‑mutated AML Novel TKI with activity against FLT3 mutations. Convenient oral regimen which can be used in an outpatient setting. Improves OS and remission rates compared with salvage chemotherapy. Manageable tolerability profile. presentation and can be used as prognostic factors to predict treatment ou
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