On June 30, 2021, the Food and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.
Efficacy was evaluated in Study JZP458-201 (NCT04145531), an open-label, multi-cohort, multicenter trial in 102 patients with ALL or LBL with hypersensitivity to E. coli-derived asparaginase as a component of a multi-agent chemotherapeutic regimen.
The median age was 10 years with a range of 1 to 24 years. Patients receivedasparaginase erwinia chrysanthemi intramuscularly at various dosages.
The main efficacy outcome measure was demonstration of the achievement and maintenance of nadir serum asparaginase activity (NSAA) above the level of 0.1 U/mL.
The results of modelling and simulations showed that for a dosage of 25 mg/m2 administered intramuscularly every 48 hours, the proportion of patients maintaining NSAA ≥ 0.1 U/mL at 48 hours after a dose of asparaginase erwinia chrysanthemi (recombinant) was 93.6% (95% CI: 92.6%, 94.6%).
The most common adverse reactions (incidence > 20%) were abnormal liver test, nausea, musculoskeletal pain, fatigue, infection, headache, pyrexia, drug hypersensitivity, febrile neutropenia, decreased appetite, stomatitis, bleeding, and hyperglycaemia.
When replacing a long-acting asparaginase product, the recommended dosage of asparaginase erwinia chrysanthemi (recombinant) is 25 mg/m2 administered intramuscularly every 48 hours for the required duration of asparaginase activity.
View full prescribing information for asparaginase erwinia chrysanthemi (recombinant) here.
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