FDA Approves New Dosing Schedule for Jazz Pharmaceuticals’ Rylaze

The FDA has approved Jazz Pharmaceuticals’ supplemental Biologics License Application (sBLA) for an additional dosing schedule for Rylaze (asparaginase erwinia chrysanthemi recombinant) to treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) and who have developed hypersensitivity to E. coli-derived asparaginase.

First approved in 2021, Rylaze is part of a multi-agent chemotherapeutic regimen administered on a Monday-Wednesday-Friday dosing regimen, where the patients receive 25 mg/m2 (m2 is a measurement of body surface area) intramuscularly on Monday and Wednesday mornings and 50 mg/m2 intramuscularly on Friday afternoons.

Patients can still receive 25 mg/m2 intramuscularly every 48 hours under the original dosing option.