Jazz Pharmaceuticals Announces U.S. FDA Approval of Monday/Wednesday/Friday Intramuscular Dosing Schedule for Rylaze®

FDA Approval

Jazz Pharmaceuticals Announces U.S. FDA Approval For Intramuscular Dosing Schedule for Rylaze

Rylaze dosing option provides sustained asparaginase activity throughout the course of treatment for adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma

Jazz Pharmaceuticals plc announced today that in the United States the Food and Drug Administration (FDA) has approved a Monday/Wednesday/Friday (MWF) intramuscular (IM) dosing schedule for Rylaze® (asparaginase Erwinia chrysanthemi (recombinant)-rywn) for additional organisms. Released Pharmaceutical Product License Application (sBLA). Rylaze is a combination chemotherapy for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients aged 1 month and older with hypersensitivity to E. coli-derived asparaginase. Approved in the US as part of a regimen.

Rylaze was first approved in the United States under the FDA’s Real-Time Oncology Review (RTOR) program in June 2021. Approval with a dosing regimen of 25 mg/m2 intramuscular injection every 48 hours addresses a pressing patient need for a non-E. coli asparaginase treatment option while clinical trials evaluating additional dosing and dosing options are ongoing. I responded.

“With the addition of a Monday/Wednesday/Friday dosing schedule for Rylaze, patients will have another dosing option, which provides sustained asparaginase activity throughout the entire course of Rylaze treatment”, “Jazz has been consistently committed to ensuring access to the reliable, high-quality supply of this important therapy so patients and healthcare providers have the opportunity to complete the full course of asparaginase therapy. As part of our efforts to improve patient and healthcare provider experience with Rylaze, we have evaluated additional dosing and administration options, and are also seeking approval for Rylaze globally.”

Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, Jazz Pharmaceuticals


“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”, “Rylaze is an effective and reliable treatment option for patients with ALL and LBL that have developed hypersensitivity to an E. coli-derived asparaginase.”

Dr. Luke Maese, associate professor at the University of Utah, Primary Children’s Hospital and Huntsman Cancer Institute

The MWF dosing option was approved by the FDA under the RTOR program based on data from the intramuscular portion of a Phase 2/3 study (JZP458-201 or AALL1931) developed and conducted in close collaboration with the Children’s Oncology Group. (COG) and was the basis for the first approval of Rylaze in June 2021.

Results showed that a dosing regimen of 25 mg/m2 im on Monday morning and Wednesday morning and 50 mg/m2 im on Friday afternoon resulted in nadir serum asparaginase levels in more than 90% of patients. , showed a positive benefit-risk profile. Activity (NSAA) ≥0.1 U/ml by simulation.

Overall, the safety profile of Rylaze was consistent with the safety information reported for ALL/LBL patients receiving asparaginase and combination chemotherapy. No new safety signals were observed in this study.

Rylaze received orphan drug designation for the treatment of his ALL/LBL in June 2021 and was included in the National Comprehensive Cancer Network®’s Clinical Practice Guidelines in Oncology (NCCN Guidelines®) in July 2021 . Jazz also completed the submission of an sBLA to the FDA for approval of the intravenous route of administration of Rylaze and a Marketing Authorization Application (MAA) for JZP458 to the European Medicines Agency.

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