Jazz's novel asparaginase Enrylaze garners EU approval for two blood cancers

22 Sep 2023
firstwordpharma.com
Drug ApprovalClinical ResultClinical StudyAccelerated Approval
The European Commission approved Jazz Pharmaceuticals’ Enrylaze (crisantaspase) for use in certain patients with acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL), the company reported. The therapy, which is also authorised in the US and Canada as Rylaze, is an Erwinia-derived asparaginase developed using recombinant technology.
Specifically, Enrylaze is indicated in the EU as a component of a multi-agent chemotherapeutic regimen for the treatment of ALL and LBL in adult and paediatric patients who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. Jazz’s drug can be given by both intravenous infusion and intramuscular injection, with dosing on either alternate days or via a Monday/Wednesday/Friday schedule.
The approval is based on data from a Phase II/III trial that included 228 paediatric and adult patients with ALL and LBL who had developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. Results showed that with intravenous administration of Enrylaze, the proportion of patients maintaining nadir serum asparaginase activity (NSAA) levels ≥0.1 U/mL at 48 hours after a dose was 89.8% and 40% after 72 hours. Meanwhile, intramuscular administration of the drug achieved sustained asparagine activity in 95.9% of patients at 48 hours after a dose and 89.8% of patients at 72 hours.
Jazz noted that the safety profile of Enrylaze, also known as JZP458, was consistent with the reported safety information for patients with ALL/LBL receiving asparaginase with combination chemotherapy. The most frequent serious adverse reactions were febrile neutropenia, pyrexia, vomiting, sepsis, medicinal product hypersensitivity, nausea and pancreatitis.
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