Overview
Bendamustine is a nitrogen mustard drug indicated for use in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine is a bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups that covalently bond to other molecules. Through this function as an alkylating agent, bendamustine causes intra- and inter-strand crosslinks between DNA bases resulting in cell death. It is active against both active and quiescent cells, although the exact mechanism of action is unknown.
Background
Bendamustine is a nitrogen mustard drug indicated for use in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine is a bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups that covalently bond to other molecules. Through this function as an alkylating agent, bendamustine causes intra- and inter-strand crosslinks between DNA bases resulting in cell death. It is active against both active and quiescent cells, although the exact mechanism of action is unknown.
Indication
Bendamustine is indicated for use in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Associated Conditions
- Chronic Lymphocytic Leukemia
- Follicular Non-Hodgkin's Lymphoma Refractory
- Refractory Hodgkin Lymphoma
- Refractory Mantle Cell Lymphoma
- Waldenström's Macroglobulinemia (WM)
- Recurrent multiple myeloma
- Refractory indolent B cell non-hodgkin lymphoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/04 | Phase 2 | Not yet recruiting | |||
2025/05/14 | Phase 3 | Recruiting | |||
2025/05/08 | Phase 2 | Not yet recruiting | Sun Yat-sen University | ||
2025/04/24 | Not Applicable | Not yet recruiting | |||
2025/04/04 | Phase 3 | Not yet recruiting | |||
2025/03/03 | Phase 2 | Not yet recruiting | Christine Ryan | ||
2025/02/26 | Phase 3 | Recruiting | |||
2025/01/07 | Phase 4 | Not yet recruiting | Xiuhua Sun | ||
2025/01/03 | Phase 2 | Not yet recruiting | Sun Yat-sen University | ||
2024/08/20 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Accord Healthcare, Inc. | 16729-251 | INTRAVENOUS | 100 mg in 20 mL | 12/8/2022 | |
| Accord Healthcare, Inc. | 16729-250 | INTRAVENOUS | 25 mg in 5 mL | 12/8/2022 | |
| Cephalon, LLC | 63459-390 | INTRAVENOUS | 25 mg in 5 mL | 10/27/2022 | |
| Cephalon, LLC | 63459-396 | INTRAVENOUS | 180 mg in 2 mL | 10/27/2022 | |
| Apotex Corp | 60505-6095 | INTRAVENOUS | 25 mg in 1 1 | 6/20/2023 | |
| Slayback Pharma LLC | 71225-120 | INTRAVENOUS | 25 mg in 1 mL | 12/7/2022 | |
| Apotex Corp | 60505-6096 | INTRAVENOUS | 100 mg in 1 1 | 6/20/2023 | |
| BluePoint Laboratories | 68001-571 | INTRAVENOUS | 25 mg in 5 mL | 3/29/2024 | |
| Meitheal Pharmaceuticals Inc. | 71288-103 | INTRAVENOUS | 100 mg in 20 mL | 6/5/2023 | |
| Eagle Pharmaceuticals, Inc | 42367-521 | INTRAVENOUS | 100 mg in 1 1 | 5/9/2019 |
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 |
|---|---|---|---|---|---|
| BEMUNAT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/VIAL USP | SIN15258P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100.00 mg | 6/5/2017 | |
| BEMUNAT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 25 MG/VIAL USP | SIN15257P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 25.00mg | 6/5/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bendamustine Hydrochloride for Injection | 国药准字H20249779 | 化学药品 | 注射剂 | 12/25/2024 | |
| Bendamustine Hydrochloride for Injection | 国药准字H20249778 | 化学药品 | 注射剂 | 12/25/2024 | |
| Bendamustine Hydrochloride for Injection | 国药准字H20253886 | 化学药品 | 注射剂 | 4/15/2025 | |
| Bendamustine Hydrochloride for Injection | 国药准字H20244529 | 化学药品 | 注射剂 | 7/30/2024 | |
| Bendamustine Hydrochloride for Injection | 国药准字H20213019 | 化学药品 | 注射剂 | 1/12/2021 | |
| Bendamustine Hydrochloride for Injection | 国药准字HJ20180087 | 化学药品 | 注射剂 | 8/1/2023 | |
| Bendamustine Hydrochloride for Injection | 国药准字H20213967 | 化学药品 | 注射剂 | 12/31/2021 | |
| Bendamustine Hydrochloride for Injection | 国药准字H20227059 | 化学药品 | 注射剂 | 4/27/2022 | |
| Bendamustine Hydrochloride for Injection | 国药准字H20244923 | 化学药品 | 注射剂 | 9/19/2024 | |
| Bendamustine Hydrochloride for Injection | 国药准字H20213749 | 化学药品 | 注射剂 | 9/24/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| BENDAMUSTINE ADVAGEN POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG | N/A | N/A | N/A | 11/25/2024 | |
| BENDINE 100 POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG | N/A | N/A | N/A | 1/8/2025 | |
| BENDAMUSTINE ADVAGEN POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 25MG | N/A | N/A | N/A | 11/25/2024 |