FDA grants Breakthrough Therapy Designation to quizartinib for relapsed/refractory FLT3-ITD acute myeloid leukemia

On 1st August 2018, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to quizartinib, an oral, highly potent and selective FMS-like tyrosine kinase 3 (FLT3) inhibitor, for the treatment of adult patients with relapsed/refractory (R/R) FLT3-ITD-mutated acute myeloid leukemia (AML).

The Breakthrough Therapy Designation granted by the FDA was based on data from the pivotal phase III randomized QuANTUM-R study, which is assessing the efficacy and safety of quizartinib (60-mg, with a 30-mg lead-in for 15 days) versus salvage chemotherapy (SC) in patients with R/R FLT3-ITD-mutated AML. Data from this study was presented by Jorge Cortes from the MD Anderson Cancer Center, Houston, Texas, at the 23rd Congress of the European Hematology Association, Stockholm, Sweden. Quizartinib significantly prolonged overall survival in patients with R/R FLT3-ITD AML compared to SC. More results from this phase III randomized study are reported here.

Jorge Cortes, in an interview with the AML Global Portal (AGP), highlighted that the QuANTUM-R trial was a “very positive study”, and he hopes that it leads to a “regulatory approval” for quizartinib as it “offers an advantage” over the current treatment options for these difficult to treat patients.

  1. BioSpace: FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML. 2018 Aug 01. https://www.biospace.com/article/releases/fda-grants-breakthrough-therapy-designation-to-daiichi-sankyo-s-flt3-inhibitor-quizartinib-for-relapsed-refractory-flt3-itd-aml/ [Accessed 2018 Aug 01].
  2. Cortes J. et al. Quizartinib significantly prolongs overall survival in patients with FLT3-internal tandem duplication–mutated (MUT) relapsed/refractory AML in the phase 3, randomized, controlled QuANTUM-R trial. Abstract LB2600. 23rd Congress of the European Hematology Association; 2018 June 14–17, Stockholm, SE.
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