Asparaginase Erwinia chrysanthemi (recombinant)-rywn has been approved by the FDA as part of a treatment regimen for adult and pediatric patients with acute lymphocytic leukemia (ALL) and lymphoblastic lymphoma (LBL) who have developed hypersensitivity to E. coli-derived asparaginase.
This decision is based on efficacy data from Study JZP458-201 (NCT04145531), which enrolled 102 patients ages 1 to 24 with ALL or LBL and hypersensitivity to E. coli-derived asparaginase within a chemotherapy regimen. Asparaginase Erwinia chrysanthemi was administered intramuscularly at various dosages. The primary endpoint of the study was the achievement and maintenance of nadir serum asparaginase activity above 0.1 U/mL. At a dosage of 25 mg/m2, 93.6% of patients achieved the primary endpoint at 48 hours after administration.
Adverse events occurring in >20% of patients included abnormal liver test, nausea, musculoskeletal pain, fatigue, infection, headache, pyrexia, drug hypersensitivity, febrile neutropenia, decreased appetite, stomatitis, bleeding, and hyperglycemia.
Recommended dosage of asparaginase Erwinia chrysanthemi is 25 mg/m2 administered intramuscularly every 49 hours for the required duration of asparaginase activity.
Source: FDA press release, June 30, 2021.