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The approval is based on data from the Phase III single-arm, open-label '1053' trial of Lumoxiti monotherapy in 80 patients who have received at least two prior therapies, including a purine nucleoside analog.
Instead, the parasite must make purines indirectly, by using an enzyme called purine nucleoside phosphorylase (PNP) to make a purine precursor called hypoxanthine.
A recently published study from UCSD reports that some autistic patients have evidence of a purine metabolism defect.
According to the company, Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use has been approved for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.
Forodesine hydrocloride is an orally-available transition-state analog inhibitor of purine nucleoside phosphorylase (PNP), a purine salvage pathway enzyme that is essential for the proliferation of T-cells and B-cells.
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