The expanded approval adds new dosing options for Rylaze, which provides sustained asparaginase activity for adult and paediatric patients with acute lymphoblastic leukaemia or lymphoblastic lymphoma, throughout the treatment
Rylaze was initially approved in the US. (Credit: Jazz Pharmaceuticals plc)
Jazz Pharmaceuticals announced that the US Food and Drug Administration (FDA) has expanded approval for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn).
In June last year, Rylaze was approved in the US for the treatment of acute lymphoblastic leukaemia (ALL) or lymphoblastic lymphoma (LBL) in adults and children as young as one month, with hypersensitivity to E. coli-derived asparaginase.
The US health agency approved the company’s supplemental Biologics License Application (sBLA) to add a Monday/Wednesday/Friday (MWF) intramuscular (IM) dosing schedule for Rylaze.
The expanded approval allows a dosing schedule of 25mg/m2, administered IM every 48 hours, and meets the immediate patient need for a non-E.coli-derived asparaginase treatment option, said the company.
Jazz Pharmaceuticals executive vice president, and research and development global head Rob Iannone said: “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.”
The US FDA approved the MWF dosing option for Rylaze based on data from the Phase 2/3 trial, under its Real-Time Oncology Review (RTOR) programme.
Jazz conducted the Phase 3 trial in collaboration with the Children’s Oncology Group (COG), which was also the basis for the initial approval in June last year.
In the study, a dosing regimen of 25mg/m2, administered intramuscularly on Monday morning and Wednesday morning, and 50mg/m2 on Friday afternoon, showed a positive benefit-to-risk profile.
Rylaze showed a safety profile that was consistent with the reported safety information for patients with ALL/LBL receiving asparaginase with combination chemotherapy, with no new safety signals observed.
Furthermore, Jazz has submitted an sBLA to the FDA, seeking approval for an intravenous (IV) administration for Rylaze, along with a Marketing Authorisation Application (MAA) with the European Medicines Agency.