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.

The company’s action seemingly also reflects the FDA Oncology Center of Excellence’s push to remove “dangling” accelerated approval drugs more quickly, especially when other therapeutic alternatives exist, rather than letting them linger on

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