Posted by Michael Wonder on 22 Nov 2022
GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorisation
22 November 2022 - GSK today announced it has initiated the process for withdrawal of the US marketing authorisation for Blenrep (belantamab mafodotin-blmf) following the request of the US FDA.
This request was based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations.
