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Erwinia asparaginase
Erwinia asparaginase depletes the amino acid asparagine in the bloodstream, starving leukemic cells that cannot synthesize their own asparagine.
Erwinia asparaginase depletes the amino acid asparagine in the bloodstream, starving leukemic cells that cannot synthesize their own asparagine. Used for Acute lymphoblastic leukemia (ALL), as part of combination chemotherapy regimens, Acute myeloid leukemia (AML), in select cases.
At a glance
| Generic name | Erwinia asparaginase |
|---|---|
| Also known as | Rylze or native Erwinia asparaginase, Erwinase®, ERWINAZE®, ERWINIA CHRYSANTHEMI, ERWINASE® |
| Sponsor | Andrew E. Place, MD |
| Drug class | Enzyme |
| Target | Asparagine |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Asparaginase is an enzyme that catalyzes the hydrolysis of asparagine to aspartic acid and ammonia. Acute lymphoblastic leukemia (ALL) cells are dependent on exogenous asparagine for protein synthesis and survival, whereas normal cells can synthesize asparagine endogenously. By depleting circulating asparagine, the enzyme selectively inhibits leukemic cell growth. Erwinia asparaginase is derived from the bacterium Erwinia chrysanthemi and is used as an alternative to E. coli asparaginase, particularly in patients who develop hypersensitivity to the E. coli formulation.
Approved indications
- Acute lymphoblastic leukemia (ALL), as part of combination chemotherapy regimens
- Acute myeloid leukemia (AML), in select cases
Common side effects
- Hypersensitivity reactions
- Pancreatitis
- Hepatotoxicity
- Coagulopathy
- Hyperglycemia
- Neurotoxicity
Key clinical trials
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL (PHASE2)
- Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (PHASE2)
- Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia (PHASE2)
- Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia (PHASE1)
- Venetoclax Basket Trial for High Risk Hematologic Malignancies (PHASE1)
- A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Erwinia asparaginase CI brief — competitive landscape report
- Erwinia asparaginase updates RSS · CI watch RSS
- Andrew E. Place, MD portfolio CI