FDA Grants Approval to New Dosing Regimen for Asparaginase Erwinia Chrysanthemi in ALL/LBL

The FDA has approved a new dosing regimen for asparaginase erwinia chrysanthemi (Rylaze) for patients with acute lymphocytic leukemia (ALL) or lymphoblastic lymphoma (BLL), according to a press release from the FDA. Under the new regimen, patients can now receive asparaginase erwinia chrysanthemi at an intramuscular dose of 25 mg/m² on Monday and Wednesday mornings and 50 mg/m² intramuscularly on Friday afternoons or 25 mg/m² intramuscularly every 48 hours.

The approval was based on pharmacokinetics data from the phase 2/3 JZP458-201 study (NCT04145531) in which the agent was assessed at various dosages, resulting in the development of a model to predict serum asparaginase activity at various timepoints. Simulated models estimated that the proportion of patients maintaining a nadir serum asparaginase activity of at least 0.1 U/mL was 91.6% (95% CI: 90.4%, 92.8%) after the 25 mg/m² Wednesday morning dose and 91.4% (95% CI: 90.1%, 92.6%) after the 50 mg/m² Friday afternoon dose.

The most common adverse effects (AEs) of the agent at its recommended doses included neutropenia, anemia, and thrombocytopenia. Frequent nonhematological AEs occurring in more than 20% of patients included abnormal liver test, nausea, musculoskeletal pain, infection, fatigue, headache, febrile neutropenia, pyrexia, hemorrhage, stomatitis, abdominal pain, decreased appetite, drug hypersensitivity, hyperglycemia, diarrhea, pancreatitis, and hypokalemia.

Reference

FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant). News release. FDA. November 18, 2022. Accessed November 18, 2022. bit.ly/3XecGoP