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European Commission approved JZP458 for the treatment of ALL and lymphoblastic lymphoma

By Sabina Ray

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Sep 25, 2023

Learning objective: After reading this article, learners will be able to cite a new clinical development in ALL.


On September 21, 2023, it was announced that JZP458 received approval from the European Commission for use in a multi-agent chemotherapy treatment in adult and pediatric patients (≥1 month) with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL), who have developed silent inactivation or hypersensitivity to E.Coli derived asparaginase.

JZP458 is an Erwina-derived asparaginase that was developed with next-generation recombinant technology and has a safety profile consistent with other asparaginase therapies. The approval is based on data from JZP458-201 (NCT04145531), a phase II/III clinical trial investigating  JZP458 chemotherapeutic regimen in 228 patients with ALL or LBL with sensitivity or inactivated E.Coli-derived asparaginase.

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