GSK’s Blenrep: 15 Days From Confirmatory Trial Failure To Withdrawal Announcement

The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.

Speed
FDA and GSK moved with considerable speed in taking Blenrep off the market followed a failed confirmatory trial. • Source: Shutterstock

GSK plc’s announcement of a planned US withdrawal of the multiple myeloma drug Blenrep (belantamab mafodotin-blmf) a mere 15 days after disclosing that the DREAMM-3 trial was unsuccessful appears to set a new standard for speed of voluntary removal following a confirmatory trial failure.

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