Asparaginase erwinia chrysanthemi (recombinant)-rywn

(Rylaze®)

Asparaginase erwinia chrysanthemi (recombinant)-rywn

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Drug updated on 5/17/2024

Dosage FormInjection (intramuscular; 10 mg/0.5 mL)
Drug ClassAsparagine specific enzymes
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated 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 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

Summary
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  • Asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.
  • The study is derived from one study documenting randomized controlled trial AALL1931, which specifically explored Rylaze's efficacy and safety profile compared to existing E. coli-derived asparaginase therapies.
  • The study included 167 patients with ALL/LBL who exhibited hypersensitivity or silent inactivation to E. coli-derived asparaginases, making it particularly relevant for this subgroup of patients.
  • In terms of effectiveness, the primary measure was the patients' ability to maintain an adequate nadir serum asparaginase activity at 72 and 48 hours during the first treatment course; results demonstrated robust efficacy, especially in the cohort receiving dosage levels: 25/25/50 mg/m^2 MWF, where the majority achieved desired NSAA levels indicating enhanced efficacy with higher doses or altered dosing regimens.
  • Safety-wise, grade 3/4 treatment-related adverse events occurred notably in about half the participants, including pancreatitis, allergic reactions, etc., leading some subset discontinuation but overall aligns with expected adverse effects common among other similar treatments, suggesting no significantly added risk when switching over from traditional options.
  • Compared to other Asparaginase treatments, Rylaze presents itself promisingly for ALL/LBL intolerant patients toward E.coli derived ones due to its maintained enzyme activity crucial for effective therapy while having consistent safety profiles. However, direct comparisons on aspects such as long-term outcomes, survival rates, were not detailed hence comprehensive evaluations involving broader indicators would further underscore its positioning amongst existing treatments.

Product Monograph / Prescribing Information

Document TitleYearSource
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) Prescribing Information.2022Jazz Pharmaceuticals Inc., Palo Alto, CA

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Recombinant Erwinia asparaginase (JZP458) in acute lymphoblastic leukemia: results from the phase 2/3 AALL1931 study.
167Subjects
F: 38%
M: 62%
2023Blood: American Society of Hematology

Sex Distribution:

F:38%
M:62%
167Subjects

Year:

2023

Source:Blood: American Society of Hematology