On 17 July, US regulator the Food and Drug Administration (FDA) voted 5-3 against GlaxoSmithKline's proposed dosing regimen for belantamab mafodotin in relapsed/refractory multiple myeloma (r/r MM), citing insufficient benefit-risk balance with bortezomib/dexamethasone combinations. Separately, the institution rejected 10-1 Otsuka Pharmaceutical's post-traumatic stress disorder (PTSD) application for brexpiprazole on 18 July, questioning its efficacy alongside sertraline in Trials 071/072.

GlaxoSmithKline and Otsuka affirmed commitment to ongoing FDA discussions ahead of final decisions by 23 July. The setbacks highlight regulatory scrutiny of combination therapies, with belantamab mafodotin's ocular toxicity and brexpiprazole's marginal effect sizes weighing on approvals. Both companies plan to pursue additional data to address concerns.

According to PharmCube's NextBiopharm® database, belantamab mafodotin leads the race in the BCMA-targeting ADC race, which includes three molecules in human studies (image below) and five pre-clinical candidates. Click here to request a free trial for NextBiopharm®.