Japan’s Astellas Pharma has secured FDA approval for Xospata (gilteritinib) for the treatment of adult patients with relapsed or refractory Acute Myeloid Leukaemia (AML) with a FLT3 mutation.
Xospata is an oral therapy and, to date, is the first and only FLT3-targeting therapy to be approved by the FDA for this population.
The treatment has demonstrated inhibitory activity against two different mutations, FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD).
Impacting approximately 30% of AML patients, the FLT3-ITD mutation is associated with worsened disease-free survival and overall survival.
FLT3-TKD mutations impact approximately 7% of AML patients and, although the impact of these mutations is less clear, they have been associated with treatment resistance.
“Our ability to use precision medicine to help patients with FLT3-mutated AML takes an important step forward with the approval of Xospata,” said Alexander Perl, Abramson Cancer Centre, University of Pennsylvania.
“There is an urgent need in the clinic for more targeted agents to help patients whose disease is either refractory to the initial therapy, or who have relapsed.”
The approval was based on an interim analysis of the following endpoints in the ADMIRAL clinical trial.