Leah Lawrence

Cancer Nursing Today nonprod

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.&nbsp;&nbsp;The new schedule is Monday/Wednesday/Friday (MWF) intramuscular dosing.&nbsp;&nbsp;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. &nbsp;&ldquo;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,&rdquo; said Luke Maese, MD, associate professor at the University of Utah, Primary Children&rsquo;s Hospital and Huntsman Cancer Institute. &ldquo;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.&rdquo;&nbsp;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 &ge;90% of the patients achieving nadir serum asparaginase activity (NSAA) &ge;0.1 U/mL by simulation.&nbsp;The drug&rsquo;s safety has been consistent with the reported safety for patients with ALL/LBL receiving asparaginase with combination chemotherapy. &nbsp;Rylaze currently has orphan drug designation for patients with ALL/LBL and is part of the National Comprehensive Cancer Network guidelines.<h3>Reference</h3><a href="https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-us-fda-approval-of-mondaywednesdayfriday-intramuscular-dosing-schedule-for-rylaze-asparaginase-erwinia-chrysanthemi-recombinant-rywn-301683034.html" target="_blank" rel="noopener">Jazz Pharmaceuticals announces U.S. FDA approval of Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze&reg; (asparaginase erwinia chrysanthemi (recombinant)-rywn)</a>

New Dosing Schedule Approved for Rylaze

Treatment

A recently approved TIW schedule provides new option for patients with ALL or LBL receiving asparaginase.