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Rylaze Received FDA Approval of a New Dosing Regimen

JHOP - December 2022 Vol 12, No 6 - FDA Oncology Update
NEW INDICATIONS/DOSING

On November 18, 2022, the FDA approved a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze; Jazz Pharmaceuticals). With this new regimen, asparaginase erwinia chrysanthemi (recombinant) is administered as 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. The drug is also approved at a dose of 25 mg/m2 intramuscularly every 48 hours.

Asparaginase erwinia chrysanthemi (recombinant) was previously approved as a component of a multi-agent chemotherapy regimen for patients aged ≥1 month with acute lymphoblastic leukemia or lymphoblastic lymphoma who have hypersensitivity to Escherichia coli–derived asparaginase.

This new dosing regimen was approved based on results in 225 patients in the open-label multicenter Study JZP458-201. In the study, the drug was used at various dosages and routes of administration, and the results were used to develop a model to predict the serum asparaginase activity at various time points.

All patients who received the recommended dosages of asparaginase erwinia chrysanthemi (recombinant) as a component of a multi-agent chemotherapy regimen had neutropenia, anemia, or thrombocytopenia. The most common (>20%) nonhematologic adverse events were 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.

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