Shots:

• The US FDA’s ODAC has voted 12-0 in favor of the demonstrated benefit of belantamab mafodotin monothx. outweighing the risks for patients with r/r MM prior treated with at least four therapies including an immunomodulatory agent- a proteasome inhibitor- and an anti-CD38 antibody. Two committee members could not participate in the final vote
• The recommendation is based on DREAMM program including the pivotal DREAMM-2 study which enrolled heavily pre-treated patients who had actively progressing MM that had worsened despite treated with SOC
• Belantamab mafodotin is an investigational ADC comprising a humanized anti- BCMA mAb conjugated to the cytotoxic agent auristatin F via a non-cleavable linker and has received the US FDA’s BT designation in 2017 and PR in early 2020. The therapy’s MAA is under EMA’s accelerated assessment

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