GSK’s Belantamab Mafodotin Receives the US FDA Advisory Committee’s Recommendation to Treat Relapsed/Refractory Multiple Myeloma

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

Click here to read full press release/ article | Ref: GSK | Image: CityAM