Belantamab mafodotin
- Generic Name
- Belantamab mafodotin
- Brand Names
- BLENREP
- Drug Type
- Biotech
- CAS Number
- 2050232-20-5
- Unique Ingredient Identifier
- DB1041CXDG
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/05/06 | Phase 2 | Recruiting | |||
2023/04/27 | N/A | Terminated | |||
2023/03/29 | Phase 2 | Recruiting | |||
2023/02/06 | Phase 1 | Recruiting | |||
2022/10/17 | Phase 1 | Not yet recruiting | Hellenic Society of Hematology | ||
2022/10/10 | Phase 1 | Recruiting | Hellenic Society of Hematology | ||
2022/09/27 | Phase 1 | Active, not recruiting | |||
2022/08/09 | Phase 1 | Withdrawn | |||
2022/07/18 | Phase 3 | Withdrawn | |||
2022/05/26 | N/A | Completed | Fondazione EMN Italy Onlus |
FDA Approved Products
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