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GSK Reports EMA's Acceptance of MAA for Belantamab Mafodotin to Treat Relapsed or Refractory Multiple Myeloma

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GSK Reports EMA's Acceptance of MAA for Belantamab Mafodotin to Treat Relapsed or Refractory Multiple Myeloma

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  • The MAA is based on DREAMM-2 P-II study (DRiving Excellence in Approaches to Multiple Myeloma) study which involves assessing of Belantamab Mafodotin in heavily pre-treated patients with MM who were refractory to an immunomodulatory drug and a proteasome inhibitor and were refractory and/or intolerant to an anti-CD38Ab
  • The study resulted in 31% ORR with a 2.5 mg/kg regimen of single agent belantamab mafodotin with consistent safety and tolerability profile- published in The Lancet Oncology
  • Belantamab Mafodotin is an anti-B cell maturation antigen (BCMA) mAb conjugated to the cytotoxic agent auristatin F via non-cleavable linker and has been accepted for accelerated assessment by the EMA’s CHMP- also received EMA’s PRIME designation in 2017

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Ref: GSK | Image: GSK


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