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Gilteritinib (Xospata®) FDA approved for relapsed or refractory AML harbouring FLT3 mutations
By: scienterrific | Last updated: 29 November 2018 | In: US FDA Onc\Haem Approvals, Haematology, Targeted Therapies
Article Keywords
ASP2215, FLT3 D835, FLT3 I836, FLT3 ITD, gilteritinib, Xospata, FDA, AML, leukaemia, Astellas, FLT3
On 28 November 2018, the FDA approved gilteritinib (Xospata® [ASP2215], Astellas) for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukaemia (AML) harbouring FLT3 mutations as confirmed by an FDA-approved companion diagnostic test (CDx).
ADMIRAL trial
The open-label, multicentre ADMIRAL trial (NCT02421939) enrolled 138 adult R/R AML patients carrying FLT3 ITD, D835, or I836 mutations as established by the CDx. Patients received gilteritinib 120 mg/day orally until lack of clinical benefit or an unacceptable toxicity.
At a median follow-up of 4.6 (range: 2.8-15.8) months, 21% (29/138; 95% CI, 14.5-28.8) of patients had either a complete remission (CR) or a CR with partial hematologic recovery (CRh).
At baseline, 106/138 patients were dependent on red blood cell (RBC) and/or platelet transfusions. During any 56-day post-baseline period, 31.1% (33/106) of patients became independent of these transfusions. Among the 32 patients with baseline-independence of RBC or platelet transfusions, 53.1% (17/32) remained independent of transfusion during any 56-day post-baseline period.
Safety
Common adverse reactions in ≥20% of patients included myalgia/arthralgia, transaminase increase, fatigue/malaise, pyrexia, non-infectious diarrhoea, dyspnoea, oedema, rash, pneumonia, nausea, stomatitis, cough, headache, hypotension, dizziness and vomiting.
Together with the FDA approval of gilteritinib, the label of the CDx to detect the FLT3 mutation in patients with AML – the LeukoStrat CDx FLT3 Mutation Assay (Invivoscribe Technologies) – was expanded to include use with gilteritinib.
Disclaimer
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
© Copyright 2018 MediPaper Medical Communications Ltd.
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