The Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma.
Blenrep consists of a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate.
The new approval is based on data from the phase 3 DREAMM-7 trial.
The drug had initially received accelerated approval in 2020 for R/R multiple myeloma based on data from the DREAMM-2 study, however, was subsequently removed from the market in 2022 after a confirmatory trial (DREAMM-3) failed to meet the requirements for traditional approval by the FDA.
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Author summary: Blenrep approved for R/R multiple myeloma treatment.