Rylaze Receives FDA Approval: A Key Treatment Option For Patients With Acute Lymphoblastic Leukaemia
FDA Approval Of Rylaze Fills Asparaginase Shortage Gap, Offers New Hope For ALL/LBL Patients
In June 2021, the U.S. Food and Drug Administration (FDA) approved Rylaze (JZP458, recombinant Owenella asparaginase) for the treatment of patients with acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL)who have an allergic reaction to E. coli-derived asparaginase.
This approval provides a key alternative for patients facing asparaginase supply shortages and allergic reactions, ensuring they can continue to receive essential multi-agent chemotherapy regimens.
Developed by Jazz Pharmaceuticals, Rylaze is a recombinant Owen’s bacillus asparaginase, produced through genetically engineered technology to provide a more stable supply and optimised pharmacokinetic profile compared to natural Owen’s bacillus asparaginase.
Its approval marks an important advance in the field of ALL/LBL therapy, particularly for patients who are unable to use Pegaspargase or Ehrlichia asparaginase (Elspar) due to allergy or supply issues.
Clinical Need And Mechanism Of Action Of Rylaze
Why is asparaginase critical for ALL/LBL treatment?
Acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) are aggressive haematological malignancies that rely on asparaginase as a central component of multi-agent chemotherapy regimens.
Asparaginase inhibits cancer cell proliferation by depleting blood asparagine, an amino acid essential for the growth of leukaemia cells, while normal cells are less affected as they can synthesise asparagine on their own.
However, there are two major problems with conventional E. coli-derived asparaginases (e.g., peptonase):
Allergic reactions: about 10-30% of patients develop antibodies, leading to allergic reactions or drug inactivation.
Supply shortage: in recent years, the global supply of asparaginase has been unstable, affecting patient treatment continuity.
The approval of Rylaze directly addresses both of these issues, providing clinicians and patients with a reliable alternative.
Pivotal Clinical Trial Data Supports Rylaze’s Efficacy And Safety
The approval of Rylaze is based on data from the AALL1931 study, a multicentre, open-label Phase 2/3 clinical trial evaluating the pharmacodynamics, safety and tolerability of Rylaze in patients with ALL/LBL.
Key Findings:
94% of patients maintained asparaginase activity ≥0.1 U/mL (the critical threshold for therapeutic effectiveness) during treatment.
The most common adverse reactions (≥20%) included abnormal liver function, nausea, bone pain, infection, fatigue, headache, fever, and febrile neutropenia.
Compared to E. coli asparaginase, Rylaze was less immunogenic and had a significantly lower incidence of allergic reactions.
These data suggest that Rylaze is effective in maintaining asparagine depletion with a manageable safety profile.
Rylaze dosing options and commercialisation progress
Flexible Dosing Options
Rylaze is available in two dosing regimens:
Intramuscular (IM): 25 mg/m² three times per week (Mon/Wed/Fri).
Intravenous (IV): 25 mg/m² every 48 hours.
This flexibility allows physicians to adapt the treatment regimen to the patient’s tolerance and clinical needs.
CONCLUSION: Rylaze Provides Critical Coverage For ALL/LBL Patients
The approval of Rylaze marks an important milestone in the treatment of ALL/LBL, providing a reliable alternative to asparaginase for patients facing allergy or supply issues.
Its stable pharmacodynamic profile, low immunogenicity and flexible dosing regimen make it a valuable therapeutic tool in clinical practice. In the future, with further research, the application of Rylaze may be further expanded to benefit more patients.
However, DengYue’s efforts to increase the affordability of the medicine are critical to ensuring that more patients benefit from it.
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Information from DengYueMed, China Drug Import and Export Wholesaler offers this information as a guide, not a substitute for professional medical advice. Consult your doctor before any treatment.
