Jazz Pharmaceuticals has won FDA approval for a revised dosing schedule for its blood cancer therapy Rylaze, giving physicians the option to prescribe intramuscular doses of the drug on Monday, Wednesday and Friday.
Last year, the FDA approved Rylaze, a form of asparaginase used in multi-agent chemotherapeutic regimens, for administration to adults and children with acute lymphoblastic leukemia or lymphoblastic lymphoma every 48 hours. The approval addressed the need for an alternative to Erwinaze, a drug once distributed by Jazz that had been in short supply, while leaving scope to improve on the dosing schedule.
Jazz continued to study additional dosing and administration options after winning approval, enabling it to gather data to support the authorization of an alternative schedule. The latest FDA approval covers the administration of doses of Rylaze on Monday, Wednesday and Friday.
In its clinical trial, Jazz evaluated the effect of giving 25-mg/m2 doses intramuscularly on Monday and Wednesday mornings followed by a 50-mg/m2 shot on Friday afternoons. The schedule demonstrated a positive benefit-to-risk profile.
Luke Maese, associate professor at the University of Utah, Primary Children's Hospital and Huntsman Cancer Institute, set out the significance of the new dosing option in Jazz’s statement to disclose the news.
“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. 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,” Maese said.