The European Medicines Agency Review of Gilteritinib (Xospata) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an FLT3 Mutation.

The objective of this article is to summarize the scientific review of the application leading to regulatory approval in the EU. IMPLICATIONS FOR PRACTICE: Xospata was approved in the European Union as monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an Fms-like tyrosine kinase 3 (FLT3) mutation. Gilteritinib resulted in a clinically meaningful and statistically significant improvement of overall survival compared with salvage chemotherapy. At the time of the marketing authorization of gilteritinib, there were no approved standard therapies specifically for adult patients diagnosed with relapsed or refractory AML with FLT3 mutation. In terms of safety, the overall accepted safety profile was considered manageable.
PMID: 32154636 [PubMed - as supplied by publisher]

Source: The Oncologist - March 9, 2020 Category: Cancer & Oncology Authors: Tzogani K, Røshol H, Olsen HH, Aas IB, Dalhus ML, Håkonsen GD, Nilssen LS, Lindberg V, Økvist M, Bolstad B, Rogovska I, Karpova N, Enzmann H, Gisselbrecht C, Pignatti F Tags: Oncologist Source Type: research