Overview
Pralatrexate is an antifolate for the treatment of relapsed or refractory peripheral T-cell lymphoma . Pralatrexate was developed in response due to the inferior responses of patients using the standard therapy for their B-cells counterparts. Compared to methotrexate, pralatrexate has better accumulation in cancer cells. Pralatrexate is designed to have a higher affinity for the reduced folate carrier, a protein that is overexpressed in malignant cells and is upregulated by oncogenes. As such, pralatrexate is thought to have a better therapeutic window compared to other antifolate analogs due to the novel target of RFC. Pralatrexate was approved by the FDA on September 24, 2009. It is also being studied for other types of lymphoma and solid malignancy such as non-small-cell lung cancer, breast cancer, and bladder cancer.
Indication
Pralatrexate is indicated for the treatment of relapsed or refractory peripheral T-cell lymphoma.
Associated Conditions
- Cutaneous T-Cell Lymphoma (CTCL)
- Refractory Peripheral T-Cell Lymphoma
- Relapsed Peripheral T-Cell Lymphoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/25 | Phase 1 | Recruiting | |||
2024/08/19 | Phase 3 | Recruiting | |||
2023/10/10 | Phase 3 | Recruiting | |||
2021/02/10 | Phase 2 | Recruiting | |||
2018/07/26 | Phase 1 | Active, not recruiting | City of Hope Medical Center | ||
2017/11/29 | N/A | Completed | |||
2017/11/28 | Phase 3 | Withdrawn | Jennifer Amengual | ||
2017/11/21 | Phase 3 | Completed | |||
2017/08/07 | Phase 1 | Active, not recruiting | |||
2017/05/19 | Phase 1 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 65219-552 | INTRAVENOUS | 40 mg in 2 mL | 11/15/2022 | |
| Acrotech Biopharma Inc | 72893-003 | INTRAVENOUS | 20 mg in 1 mL | 6/1/2023 | |
| Acrotech Biopharma Inc | 72893-005 | INTRAVENOUS | 40 mg in 2 mL | 6/1/2023 | |
| Fresenius Kabi USA, LLC | 65219-550 | INTRAVENOUS | 20 mg in 1 mL | 11/15/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FOLOTYN® SOLUTION FOR INFUSION 20MG/ML | SIN14544P | INFUSION, SOLUTION | 20mg/ml | 4/30/2014 |
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 |
|---|---|---|---|---|---|
| FOLOTYN pralatrexate 40 mg in 2 mL injection, intravenous infusion vial | 192492 | Medicine | A | 2/26/2015 | |
| FOLOTYN pralatrexate 20 mg in 1 mL injection, intravenous infusion vial | 192493 | Medicine | A | 2/26/2015 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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