An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used in the proposed dosages for previously treated adult patients with relapsed/refractory multiple myeloma.
The FDA Oncologic Drugs Advisory Committee (ODAC) voted 5-3 against belantamab mafodotin (Blenrep, GSK) dosed at 2.5 mg/kg every 3 weeks in combination with bortezomib (Velcade, Takeda) and dexamethasone.
The committee additionally voted 7-1 against an initial cycle of belantamab mafodotin dosed at 2.5 mg/kg, followed by 1.9 mg/kg every 4 weeks, in combination with