GSK has started the process of withdrawing belantamab mafodotin-blmf from the U.S. market.
The FDA requested the action after a confirmatory trial of the multiple myeloma therapy failed to meet requirements specified under the agency’s accelerated approval regulations.
Belantamab mafodotin-blmf (Blenrep, GSK) is an antibody-drug conjugate comprising a humanized B-cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker.
The FDA granted accelerated approval to the agent in 2020 for adults with multiple myeloma who received
