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European Commission approved JZP458 for the treatment of ALL and lymphoblastic lymphoma
By Sabina Ray
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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.
- PR Newswire. Jazz Pharmaceuticals receives European Commission approval for Enrylaze® (a recombinant Erwinia asparaginase or crisantaspase) for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma. https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-receives-european-commission-approval-for-enrylaze-a-recombinant-erwinia-asparaginase-or-crisantaspase-for-the-treatment-of-acute-lymphoblastic-leukemia-and-lymphoblastic-lymphoma-301935590.html. Published September 21, 2023. Accessed September 22, 2023.
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