GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorisation

GSK

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.

Read GSK press release

Michael Wonder

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Michael Wonder