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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)

FDA Approved Products

Blenrep
Manufacturer:GlaxoSmithKline LLC
Route:INTRAVENOUS
Strength:50 mg in 1 mL
Approved: 2022/02/28
NDC:0173-0896

Singapore Approved Products

BLENREP POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG
Manufacturer:Baxter Oncology GmbH
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:100mg/vial
Online:Yes
Approved: 2022/09/21
Approval:SIN16606P

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