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# Jazz Pharma sBLA for M/W/F Rylaze Dosing
- URL: https://www.fdaweb.com/jazz-pharma-sbla-for-m-w-f-rylaze-dosing/
- Published: 2022-02-02T12:00:00.000Z
- Updated: 2026-09-14T17:30:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151068

Jazz Pharmaceuticals has submitted a Supplemental BLA for a Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) and its use as a component of a multi-agent chemotherapeutic regimen for treating acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month and older who have developed hypersensitivity to *E. coli*\-derived asparaginase.

The submission is based on data from the company’s three-cohort intramuscular administration part of the Phase 2/3 trial of Rylaze in adult and pediatric patients with ALL and LBL. “Initial results showed that in cohort 1c, a dosing regimen of Rylaze administered 25 mg/m2 on Monday and Wednesday and 50 mg/m2 on Friday demonstrated a positive benefit-to-risk profile, showing that Rylaze maintains a clinically meaningful level of nadir serum asparaginase activity (NSAA) greater than 0.1 IU/mL at both 48 and 72 hours (from Friday to Monday),” the company says. “In addition, the safety profile of Rylaze was consistent with the reported safety information for patients with ALL/LBL receiving asparaginase with combination chemotherapy.”