Belantamab Mafodotin: First Approval

Drugs. 2020 Oct;80(15):1607-1613. doi: 10.1007/s40265-020-01404-x.


Belantamab mafodotin (BLENREP; belantamab mafodotin-blmf) is a first-in-class monoclonal antibody-drug conjugate (ADC) that has been developed for the treatment of multiple myeloma by GlaxoSmithKline. The ADC comprises an antibody targeting B-cell maturation antigen (BCMA) conjugated to the microtubule inhibitor monomethyl auristatin F (MMAF). The antibody moiety binds to BCMA on the tumour cell surface, delivering the cytotoxic microtubule inhibitor MMAF to the therapeutic target. Based on preliminary results from the multinational DREAMM-2 trial, belantamab mafodotin was approved in early August 2020 in the USA for the treatment of relapsed or refractory multiple myeloma in adult patients who have received at least four prior therapies, including an anti CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. The ADC was also approved in the EU for this indication in late August 2020. This article summarizes the milestones in the development of belantamab mafodotin leading to this first approval.

Publication types

  • Review

MeSH terms

  • Adult
  • Animals
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antibodies, Monoclonal, Humanized / adverse effects
  • B-Cell Maturation Antigen / antagonists & inhibitors
  • B-Cell Maturation Antigen / metabolism
  • Cell Line, Tumor
  • Clinical Trials as Topic
  • Disease Progression
  • Drug Approval*
  • Drug Resistance, Neoplasm
  • Humans
  • Immunoconjugates / administration & dosage*
  • Immunoconjugates / adverse effects
  • Infusions, Intravenous
  • Multiple Myeloma / diagnosis
  • Multiple Myeloma / drug therapy*
  • Multiple Myeloma / mortality
  • Multiple Myeloma / pathology
  • Neoplasm Recurrence, Local / drug therapy*
  • Neoplasm Recurrence, Local / mortality
  • Neoplasm Recurrence, Local / pathology
  • Neoplasm Staging
  • Oligopeptides / administration & dosage
  • Oligopeptides / adverse effects
  • Progression-Free Survival
  • Tubulin Modulators / administration & dosage
  • Tubulin Modulators / adverse effects
  • Xenograft Model Antitumor Assays


  • Antibodies, Monoclonal, Humanized
  • B-Cell Maturation Antigen
  • Immunoconjugates
  • Oligopeptides
  • TNFRSF17 protein, human
  • Tubulin Modulators
  • monomethylauristatin F
  • belantamab mafodotin