JZP458 is a recombinant Erwinia asparaginase that utilizes a novel Pseudomonas fluorescent technology expression platform to produce an enzyme with no immunologic cross-reactivity to E.coli-derived asparaginases. JZP458 is currently being studied in an open-label, multicenter, dose confirmation, and Pharmacokinetic (PK) study of JZP458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess tolerability and efficacy by measuring asparaginase activity. For the EAP, JZP458 will be provided free of charge by the Sponsor for the duration of the program. In addition, JZP458 will continue to be provided to eligible patients at referring sites until it becomes commercially available in the US.~JZP458 will be administered per each patient's original treatment plan, as long as the patient derives clinical benefit.
This study is an Expanded Access Protocol (EAP) of JZP458 in participants with ALL/LBL who are hypersensitive to an E.coli-derived asparaginase (allergic reaction or silent inactivation) and unable to access alternative licensed treatment, to receive JZP458 treatment prior to potential Food and Drug Administration (FDA) approval and commercial availability.