On November 18, 2022, the Food and Drug Administration approved a new Monday-Wednesday-Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn. Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. It also is approved to be administered every 48 hours at a dose of 25 mg/m2 intramuscularly.

FDA approved asparaginase erwinia chrysanthemi (recombinant)-rywn in June 2021 as a component of a multi-agent chemotherapeutic regimen for 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.

The pharmacokinetics of asparaginase erwinia chrysanthemi (recombinant)-rywn were evaluated in 225 patients in Study JZP458-201 (NCT04145531), an open-label multicenter trial in which asparaginase erwinia chrysanthemi (recombinant)-rywn was administered at various dosages and routes, and the results were used to develop a model to predict serum asparaginase activity at various time points.

The determination of efficacy was based on a demonstration of the achievement and maintenance of nadir serum asparaginase activity (NSAA) above the level of 0.1 U/mL by simulation in a virtual population. The results of simulations predicted that for the Monday-Wednesday-Friday dosing regimen, the proportion of patients maintaining NSAA ≥ 0.1 U/mL was 91.6% (95% CI: 90.4%, 92.8%) after the 25 mg/m2 Wednesday morning dose of asparaginase erwinia chrysanthemi (recombinant)-rywn and 91.4% (95% CI: 90.1%, 92.6%) after the 50 mg/m2 Friday afternoon dose.

All patients treated with the recommended dosages of asparaginase erwinia chrysanthemi (recombinant)-rywn as a component of multi-agent chemotherapy experienced neutropenia, anaemia, or thrombocytopenia. The most common non-haematological adverse reactions (incidence > 20%) in patients were abnormal liver test, nausea, musculoskeletal pain, infection, fatigue, headache, febrile neutropenia, pyrexia, haemorrhage, stomatitis, abdominal pain, decreased appetite, drug hypersensitivity, hyperglycemia, diarrhoea, pancreatitis, and hypokalemia.

View full prescribing information for asparaginase erwinia chrysanthemi (recombinant)-rywn here. 

Source: FDA