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recombinant asparaginase
Recombinant asparaginase depletes the amino acid asparagine from the bloodstream, starving asparagine-dependent leukemic cells of an essential nutrient required for protein synthesis.
Recombinant asparaginase depletes the amino acid asparagine from the bloodstream, starving asparagine-dependent leukemic cells of an essential nutrient required for protein synthesis. Used for Acute lymphoblastic leukemia (ALL), Acute myeloid leukemia (AML), Lymphoma.
At a glance
| Generic name | recombinant asparaginase |
|---|---|
| Sponsor | medac GmbH |
| 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. Leukemic blasts, particularly in acute lymphoblastic leukemia (ALL), often cannot synthesize their own asparagine and depend on exogenous sources. By depleting circulating asparagine, the enzyme selectively inhibits protein synthesis in these malignant cells while normal cells can synthesize asparagine endogenously, creating a therapeutic window.
Approved indications
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia (AML)
- Lymphoma
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)
- Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (PHASE2)
- A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL) (PHASE3)
- 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:
- recombinant asparaginase CI brief — competitive landscape report
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- medac GmbH portfolio CI