US FDA Adcom Votes (3 Yes; 5 No) overall benefit-risk of belantamab mafodotin in combination with bortezomib and dexamethasone Is Not favorable at the proposed dosage in the proposed patient population; US FDA Adcom Votes (1 Yes; 7 No) overall benefit-risk of belantamab mafodotin in combination with pomalidomide and dexamethasone Is Not favorable at the proposed dosage in the proposed patient population; PFUFA date is July 23, 2025 - ODAC Meeting
Thursday, July 17, 2025 12:39:45 PMEST
VOTE: Is the overall benefit-risk of belantamab mafodotin in combination with bortezomib and dexamethasone favorable at the proposed dosage in the proposed patient population? (3 Yes; 5 No; 0 Abstain)
VOTE: Is the overall benefit-risk of belantamab mafodotin in combination with pomalidomide and dexamethasone favorable at the proposed dosage in the proposed patient population? (1 Yes; 7 No; 0 Abstain)
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VOTE: Is the overall benefit-risk of belantamab mafodotin in combination with pomalidomide and dexamethasone favorable at the proposed dosage in the proposed patient population? (1 Yes; 7 No; 0 Abstain)