FDA Approves Monday/Wednesday/Friday Intramuscular Dosing Schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Jazz Pharmaceuticals plc announced the FDA approval of a supplemental Biologics License Application (sBLA) to add a Monday/Wednesday/Friday (MWF) intramuscular (IM) dosing
schedule for Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn). Rylaze is approved for use in the U.S. as a component of a multi-agent chemotherapeutic regimen for the treatment of acute
lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase.
When first approved in the U.S. in June 2021, under the FDA Real-Time Oncology Review (RTOR) program, the approval had a dosing schedule of 25 mg/m2 administered IM every 48 hours met the
immediate patient need for a non-E.coli-derived asparaginase treatment option while the clinical trial was still ongoing to evaluate additional dosing and administration options.
