Drug updated on 4/16/2024
| Dosage Form | Injection (intramuscular; 10 mg/0.5 mL) |
| Drug Class | Asparagine 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
- 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 document reviewed was one randomized controlled trial, which investigated the efficacy and safety of Rylaze in patients with acute lymphoblastic leukemia/lymphoblastic lymphoma who developed hypersensitivity/silent inactivation to Escherichia coli-derived asparaginases.
- In this study, each dose of a pegylated E coli-derived asparaginase remaining in patients' treatment plan was substituted by 6 doses of intramuscular Rylaze on Monday/Wednesday/Friday; three different regimens were evaluated involving varying dosages.
- A total of 167 patients were enrolled across three cohorts: cohort 1a had 33 participants, cohort 1b had 83 participants, and cohort 1c had51 participants; these groups received differing dosage levels over time.
- The proportion achieving adequate nadir serum asparaginase activity at both72 hours and48 hours during the first treatment course was highest among those receiving 25/25/50 mg/m2 MWF regimen -90% (44 out of 49) and 96% (47 out of 49), respectively indicating that this dosage level may be most effective for maintaining necessary enzyme activity levels while minimizing adverse reactions.
- Grade 3 or 4 treatment-related adverse events occurred in a significant number (86 out of 167 or 51%) patients with those leading to discontinuation including pancreatitis (6%), allergic reactions (5%), increased alanineamino transferase (1%), and hyperammonemia (1%).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) Prescribing Information. | 2022 | Jazz Pharmaceuticals Inc., Palo Alto, CA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Recombinant Erwinia asparaginase (JZP458) in acute lymphoblastic leukemia: results from the phase 2/3 AALL1931 study. | 167Subjects F: 38% M: 62% | 2023 | Blood: American Society of Hematology |
Document Title
Sex Distribution:
F:38%
M:62%
167Subjects
Year:
2023
Source:Blood: American Society of Hematology