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Asparaginase Erwinia chrysanthemi

Generic Name
Asparaginase Erwinia chrysanthemi
Brand Names
Erwinaze, Rylaze, Enrylaze
Drug Type
Biotech
CAS Number
1349719-22-7
Unique Ingredient Identifier
D733ET3F9O

Overview

Asparaginase Erwinia chrysanthemi is an asparaginase-specific enzyme derived from Erwinia chrysanthemi used as an anticancer agent. It works by depleting the stores of an important amino acid called asparagine, which is involved in DNA synthesis and cell survival of malignant cells, leading to cell death. L-asparaginase was first identified in 1963, and there are different formulations of L-asparaginase, including Asparaginase Escherichia coli and a pegylated form of this enzyme, Pegaspargase. Asparaginase Erwinia chrysanthemi and Asparaginase Escherichia coli differ in their pharmacokinetic and immunogenic profiles; thus, those who are allergic to Asparaginase Escherichia coli do not cross-react to Asparaginase Erwinia chrysanthemi. Studies show that substitution of Erwinia asparaginase for E. coli-derived asparaginase following an allergic reaction has been safe and effective. Asparaginase Erwinia chrysanthemi was first approved by the FDA in November 2011 to treat patients with acute lymphoblastic leukemia (ALL) who are allergic to E. coli-derived asparaginase: it has been used as part of multi-agent chemotherapy. In June 2021, the recombinant form of asparaginase Erwinia chrysanthemi was approved by the FDA as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase.

Background

Asparaginase Erwinia chrysanthemi is an asparaginase-specific enzyme derived from Erwinia chrysanthemi used as an anticancer agent. It works by depleting the stores of an important amino acid called asparagine, which is involved in DNA synthesis and cell survival of malignant cells, leading to cell death. L-asparaginase was first identified in 1963, and there are different formulations of L-asparaginase, including Asparaginase Escherichia coli and a pegylated form of this enzyme, Pegaspargase. Asparaginase Erwinia chrysanthemi and Asparaginase Escherichia coli differ in their pharmacokinetic and immunogenic profiles; thus, those who are allergic to Asparaginase Escherichia coli do not cross-react to Asparaginase Erwinia chrysanthemi. Studies show that substitution of Erwinia asparaginase for E. coli-derived asparaginase following an allergic reaction has been safe and effective. Asparaginase Erwinia chrysanthemi was first approved by the FDA in November 2011 to treat patients with acute lymphoblastic leukemia (ALL) who are allergic to E. coli-derived asparaginase: it has been used as part of multi-agent chemotherapy. In June 2021, the recombinant form of asparaginase Erwinia chrysanthemi was approved by the FDA as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase.

Indication

Asparaginase Erwinia chrysanthemi is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma in adults and children who have developed hypersensitivity to E. coli-derived asparaginase.

Associated Conditions

  • Acute Lymphoblastic Leukaemias (ALL)
  • Lymphoblastic Lymphoma

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/09
Phase 2
Not yet recruiting
City of Hope Medical Center
2024/12/17
Phase 2
Not yet recruiting
2024/03/28
Phase 2
Recruiting
2024/03/19
Phase 2
Recruiting
2022/03/23
Phase 1
Recruiting
Andrew E. Place, MD
2022/01/14
Phase 1
Active, not recruiting
2021/06/29
N/A
APPROVED_FOR_MARKETING
2020/03/30
Phase 2
Terminated
2020/03/03
Phase 3
Recruiting
2019/04/16
Phase 3
Active, not recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Porton Biopharma Limited
81561-413
INTRAMUSCULAR, INTRAVENOUS
10000 [iU] in 1 mL
5/3/2021

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
ENRYLAZE recombinant crisantaspase 10 mg/0.5 mL solution for injection/infusion vial
423019
Medicine
A
4/16/2025
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