GSK pulls Blenrep from US market

UK pharma major GSK (LSE: GSK) has started the process of withdrawing the US marketing authorization for multiple myeloma drug Blenrep (belantamab mafodotin-blmf).

The action complies with a request from the US Food and Drug Administration (FDA) following the failure of the DREAMM-3 Phase III confirmatory trial, which failed to show that Blenrep was any better than on-market treatment. This meant that the drug did not meet the requirements of the FDA accelerated approval regulations.

GSK’s monotherapy received accelerated approval in the USA in 2020, for use in adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.