Jazz Pharmaceuticals plc announced the FDA approval of a supplemental Biologics License Application (sBLA) to add a Monday/Wednesday/Friday (MWF) intramuscular (IM) dosing schedule for Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn). 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.
"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," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "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."
"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," said Dr. Luke Maese, associate professor at the University of Utah, Primary Children's Hospital and Huntsman Cancer Institute. "Rylaze is an effective and reliable treatment option for patients with ALL and LBL that have developed hypersensitivity to an E. coli-derived asparaginase."
The MWF dosing option was approved by the FDA under the RTOR program based on data from the intramuscular administration part of the Phase 2/3 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 ≥90% of the patients achieving nadir serum asparaginase activity (NSAA) ≥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.
Rylaze was granted orphan drug designation for the treatment of ALL/LBL in June 2021 and was added to the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) in July 2021. Jazz also completed the submission of an sBLA to the FDA seeking approval for an intravenous route of administration for Rylaze as well as the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency for JZP458.
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