FDA approves Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze to treat ALL and LBL.-Jazz Pharma

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.

Rylaze was first approved in the U.S. in June 2021 under the FDA Real-Time Oncology Review (RTOR) program. The approval with 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.

The MWF dosing option was approved by the FDA under the RTOR program based on data from the intramuscular administration part of the Phase II/III trial (JZP458-201 or AALL1931), which was developed and conducted in close collaboration with the Children's Oncology Group (COG) and was the basis for the initial approval of Rylaze in June 2021. Results show 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 greater than 90% of the patients achieving nadir serum asparaginase activity (NSAA) greater than 0.1 U/mL by simulation.

Overall, the safety profile of Rylaze was consistent with the reported safety information for patients with ALL/LBL receiving asparaginase with combination chemotherapy. There were no new safety signals observed in the trial.