Voraxaze is used to treat toxic plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function.
The approval of Voraxaze was granted under priority review, a designation that is given to therapies that provide key advances in treatment or provide a treatment where there is no adequate alternative therapy.
The FDA approval is backed by data from 290 patients who were treated in 2 single-arm, open-label, multicentre trials.
The efficacy of Voraxaze was established in a subset consisting of 22 treatment-evaluable patients in one of the two clinical studies.
BTG CEO Louise Makin said the company seeks to launch the drug in the upcoming months.
"It will be sold by our existing specialty pharmaceuticals sales force, with the addition of a few extra personnel, alongside our established emergency room medicines, CroFab and DigiFab," Makin added.