FDA OKs Jazz sBLA for Mon./Wed./Fri. Rylaze Dosing

FDA has approved a Jazz Pharmaceuticals supplemental BLA to add a Monday/Wednesday/Friday (MWF) intramuscular dosing schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn). The therapy is approved for use as a component of a multi-agent chemotherapeutic regimen for treating acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase.

The MWF dosing option was approved based on data from the intramuscular administration part of the Phase 2/3 trial (JZP458-201 or AALL1931), according to the company. “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,” it says.