The European Commission (EC) has granted marketing authorization to JZP458 (Enrylaze) for use as a component of a multiagent chemotherapeutic regimen for certain patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL).
The marketing authorization is for adults and children one month and older who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase, according to a news release from Jazz Pharmaceuticals, the manufacturer of JZP458.
JZP458, which is approved in the United States and Canada, is a new Erwinia-derived asparaginase developed using a next-generation recombinant technology with a safety profile “consistent with that of other asparaginase preparations,” according to the news release.
The treatment can be administered by intravenous infusion and intramuscular injection and is dosed on alternate days or on a Monday, Wednesday, and Friday dosing schedule.
The marketing authorization follows the positive opinion issued in July 2023 by the European Medicines Agency Committee for Medicinal Products for Human Use.
The EC approval is based on data from a phase II/III trial conducted in collaboration with the Children’s Oncology Group in 228 pediatric and adult patients with ALL and LBL who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
The EC approval extends to all European Union Member States, as well as Iceland, Norway, and Liechtenstein.
Source: Jazz Pharmaceuticals, September 2023
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