Overview
Clofarabine is a purine nucleoside antimetabolite that is being studied in the treatment of cancer. It is marketed as Clolar in the U.S. and Canada, or Evoltra in Europe, Australia, and New Zealand. Clofarabine is used in paediatrics to treat a type of leukaemia called relapsed or refractory acute lymphoblastic leukaemia (ALL), only after at least two other types of treatment have failed. It is not known if the drug extends life expectancy. Its potential use in acute myeloid leukaemia (AML) and juvenile myelomonocytic leukaemia (JMML) has been investigated.
Background
Clofarabine is a purine nucleoside antimetabolite that is being studied in the treatment of cancer. It is marketed as Clolar in the U.S. and Canada, or Evoltra in Europe, Australia, and New Zealand. Clofarabine is used in paediatrics to treat a type of leukaemia called relapsed or refractory acute lymphoblastic leukaemia (ALL), only after at least two other types of treatment have failed. It is not known if the drug extends life expectancy. Its potential use in acute myeloid leukaemia (AML) and juvenile myelomonocytic leukaemia (JMML) has been investigated.
Indication
For the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphocytic (lymphoblastic) leukemia after at least two prior regimens. It is designated as an orphan drug by the FDA for this use.
Associated Conditions
- Refractory Acute Lymphoblastic Leukemia (ALL)
- Refractory Acute Myeloid Leukemia (AML)
- Relapsed Acute Lymphoblastic Leukemia (ALL)
- Refractory Langerhans cell histiocytosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/24 | Phase 1 | Recruiting | Ekaterina Laukhtina | ||
2025/05/23 | Phase 1 | Not yet recruiting | |||
2024/02/12 | Phase 2 | Recruiting | |||
2023/06/23 | Phase 2 | Recruiting | |||
2022/10/06 | Phase 1 | Terminated | Malika Kapadia | ||
2021/08/06 | Phase 2 | Recruiting | |||
2021/08/04 | Phase 2 | Recruiting | |||
2020/11/25 | Phase 2 | Recruiting | |||
2020/01/07 | Phase 2 | Withdrawn | |||
2019/06/28 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sanofi-Aventis U.S. LLC | 0024-5860 | INTRAVENOUS | 1 mg in 1 mL | 7/31/2022 | |
| Amneal Pharmaceuticals LLC | 70121-1236 | INTRAVENOUS | 1 mg in 1 mL | 12/23/2023 | |
| Accord Healthcare Inc. | 16729-431 | INTRAVENOUS | 1 mg in 1 mL | 2/25/2019 | |
| Winthrop U.S, a business of sanofi-aventis U.S. LLC | 0955-1746 | INTRAVENOUS | 1 mg in 1 mL | 12/7/2023 | |
| Mylan Institutional LLC | 67457-546 | INTRAVENOUS | 1 mg in 1 mL | 3/24/2020 | |
| Dr.Reddy's Laboratories Inc | 43598-309 | INTRAVENOUS | 1 mg in 1 mL | 7/27/2022 | |
| Gland Pharma Limited | 68083-386 | INTRAVENOUS | 1 mg in 1 mL | 11/22/2022 | |
| Eugia US LLC | 55150-326 | INTRAVENOUS | 1 mg in 1 mL | 1/21/2020 | |
| Fosun Pharma USA Inc. | 72266-108 | INTRAVENOUS | 1 mg in 1 mL | 2/15/2023 | |
| Meitheal Pharmaceuticals Inc. | 71288-128 | INTRAVENOUS | 1 mg in 1 mL | 10/23/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/29/2006 | ||
Authorised | 5/29/2006 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Evoltra Concentrate Solution for Infusion 1mg/ml | SIN14026P | SOLUTION, CONCENTRATE | 1mg/ml | 10/6/2011 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Clofarabine Injection | 国药准字H20233799 | 化学药品 | 注射剂 | 6/27/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| CLOFACORD CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/20ML | N/A | N/A | N/A | 3/26/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| EVOLTRA clofarabine 20 mg/20 mL concentrated solution for infusion vial | 154991 | Medicine | A | 10/13/2009 |