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EMA grants gilteritinib (Xospata®) regulatory review for the treatment of patients with relapsed/refractory FLT3-positive acute myeloid leukemia

Mar 5, 2019

On 1 March 2019, the European Medicines Agency(EMA) accepted a marketing authorization application and granted regulatory review to gilteritinib, a potent, oral fms-like tyrosine kinase 3 ( FLT3) inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) FLT3-positive acute myeloid leukemia (AML). 1This comes after gilteritinib received FDA approvalfor the treatment of patients with FLT3-positive R/R AML in November 2018.

The marketing authorization application is based on the results from the randomized phase III ADMIRAL study ( NCT02421939), which is assessing the efficacy of oral gilteritinib vssalvage chemotherapy in adult patients with FLT3-positive R/R AML. Interim results from the trial demonstrated a complete remission/complete remission with partial hematologic recovery rate of 21%. 2The results from the ADMIRAL trial are to be presented at the American Association for Cancer Research Annual Meeting 2019, Atlanta, USA, in March 2019.

According to the drug manufacturers, the marketing authorization application for gilteritinib to the EMA received accelerated assessment, which could result in a shorter timeframe for approval from the Committee for Medicinal Products for Human Use.

  1. Pharmafield. EMA accepts marketing authorization application for XOSPATA (gilteritinib). https://pharmafield.co.uk/pharma_news/ema-accepts-maa-for-xospatatm-gilteritinib/[Accessed 2019 Mar 04]
  2. Perl A.E.  et al. An open-label, randomized phase III study of gilteritinib versus salvage chemotherapy in relapsed or refractory FLT3 mutation-positive acute myeloid leukemia. J Clin Oncol. 35, 2017 (suppl; abstr  #TPS7067).  2017 American Society of Clinical Oncology (ASCO) Annual Meeting, 2017 June 2–6; Chicago, IL, USA.