Overview
Belantamab mafodotin, or GSK2857916, is an afucosylated monoclonal antibody that targets B cell maturation antigen conjugated to the microtubule disrupter monomethyl auristatin-F (MMAF). Belantamab mafodotin was granted FDA accelerated approval on 5 August 2020 for the treatment of multiple myeloma; however, its manufacturer began the process for withdrawal of the US marketing authorization in November 2022. In the meantime, belantamab mafodotin will be available for patients in the Risk Evaluation and Mitigation Strategy (REMS) program who can enrol in a compassionate use program.
Background
Belantamab mafodotin, or GSK2857916, is an afucosylated monoclonal antibody that targets B cell maturation antigen conjugated to the microtubule disrupter monomethyl auristatin-F (MMAF). Belantamab mafodotin was granted FDA accelerated approval on 5 August 2020 for the treatment of multiple myeloma; however, its manufacturer began the process for withdrawal of the US marketing authorization in November 2022. In the meantime, belantamab mafodotin will be available for patients in the Risk Evaluation and Mitigation Strategy (REMS) program who can enrol in a compassionate use program.
Indication
Belantamab mafodotin is indicated in the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
Associated Conditions
- Relapsed/Refractory Multiple Myeloma (RRMM)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/13 | Phase 2 | Not yet recruiting | Hellenic Society of Hematology | ||
2025/05/04 | Phase 3 | Active, not recruiting | |||
2025/03/11 | Phase 3 | Active, not recruiting | |||
2025/03/11 | Phase 3 | Active, not recruiting | |||
2024/11/07 | Phase 3 | Recruiting | |||
2024/10/23 | Phase 1 | Terminated | |||
2024/01/30 | Phase 1 | Suspended | |||
2023/12/07 | Phase 1 | Terminated | |||
2023/08/14 | N/A | Completed | |||
2023/06/28 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| GlaxoSmithKline LLC | 0173-0896 | INTRAVENOUS | 50 mg in 1 mL | 2/28/2022 |
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 |
|---|---|---|---|---|---|
| BLENREP POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG | SIN16606P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100mg/vial | 9/21/2022 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||