The U.S. Food and Drug Administration (FDA) has approved a new dosing schedule for asparaginase erwinia chrysanthami (recombinant)-rywan (Rylaze), one of the components used in a chemotherapy regimen for treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older with hypersensitivity to E. Coli-derived asparaginase.
The new schedule is Monday/Wednesday/Friday (MWF) intramuscular dosing.
Rylaze was first approved with a dosing schedule of 25 mg/m2 administered intramuscularly every 48 hours under an FDA real-time oncology review program. The clinical trial of Rylaze was still ongoing at the time.
“The expansion of the Rylaze label to include a Monday/Wednesday/Friday dosing schedule provides another option to support patients in completing their planned asparaginase treatment regimen,” said Luke Maese, MD, associate professor at the University of Utah, Primary Children’s Hospital and Huntsman Cancer Institute. “The benefit of completing the full course of asparaginase has been shown in various publications, and discontinuation of asparaginase has been associated with inferior disease-free survival.”
The new dosing schedule was approved based on data from a phase 2/3 trial looking at different dose schedules and routes of administration. The trial showed that a dosing regimen of 25 mg/m2 administered intramuscularly on Monday morning and Wednesday morning, and 50 mg/m2 administered on Friday afternoon demonstrated a positive benefit-to-risk profile, with ≥90% of the patients achieving nadir serum asparaginase activity (NSAA) ≥0.1 U/mL by simulation.
The drug’s safety has been consistent with the reported safety for patients with ALL/LBL receiving asparaginase with combination chemotherapy.
Rylaze currently has orphan drug designation for patients with ALL/LBL and is part of the National Comprehensive Cancer Network guidelines.
Jazz Pharmaceuticals announces U.S. FDA approval of Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn)