FDA grants Fast Track Designation to crenolanib for the treatment of patients with R/R FLT3-Positive AML

On 1st December 2017, the US Food and Drug Administration (FDA) granted crenolanib, a tyrosine kinase inhibitor, Fast Track designation for the treatment of patients with Fms Like Tyrosine Kinase 3 (FLT3) mutation-positive Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML).1 FLT3 mutations with Internal Tandem Duplications (ITD) occurs in approximately 30% of AML patients. These mutations often lead to poor prognosis and disease relapse in AML patients.2

Crenolanib is a selective and potent inhibitor for Platelet-Derived Growth Factor Receptor (PDGFR) α and β but it also has a high affinity for FLT3. Crenolanib binds to and inhibits both wild-type and mutated forms of FLT3, which can lead to the inhibition of FLT3-related signal transduction pathways.2

At present, crenolanib is being explored in multiple trials for newly diagnosed (NCT02283177) and relapsed/refractory (NCT02298166NCT02400281NCT01657682) AML patients with or without FLT3 mutations.

  1. GlobeNewswire: Arog Pharmaceuticals Receives FDA Fast Track Designation for Crenolanib in Relapsed or Refractory FLT3-Positive AML. 2017 Dec 1st. https://globenewswire.com/news-release/2017/12/01/1216122/0/en/Arog-Pharmaceuticals-Receives-FDA-Fast-Track-Designation-for-Crenolanib-in-Relapsed-or-Refractory-FLT3-Positive-AML.html [Accessed 2017 Dec 1st].
  2. Zimmerman E. I. et al. Crenolanib is active against models of drug-resistant FLT3-ITD−positive acute myeloid leukemia. Blood. 2013 Nov 21; 122(22): 3607-3615. DOI: 10.1182/blood-2013-07-513044. Epub 2013 Sep 17.
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