GlaxoSmithKline’s blood cancer treatment Blenrep (belantamab mafodotin-blmf) has received renewed approval from the FDA for use in adults with relapsed or refractory multiple myeloma (RRMM) who have received at least two prior therapies, reinstating the drug just three years after it was withdrawn due to a failed confirmatory study.
The new approval allows Blenrep to be used in combination with bortezomib (Velcade) and dexamethasone, providing a third-line or later option for patients whose myeloma has returned or is unresponsive to standard treatments. The decision is supported by pivotal results from the DREAMM-7 Phase III clinical trial, which demonstrated a 51% reduction in the risk of death and a tripled median progression-free survival (31.3 months vs. 10.4 months) compared to a daratumumab-based regimen.
Blenrep, an antibody-drug conjugate targeting the B-cell maturation antigen (BCMA) protein on multiple myeloma cells, previously held accelerated approval as a monotherapy. Its withdrawal followed safety concerns—most notably ocular toxicity and vision changes. The relaunch comes with a streamlined REMS program and clearer protocols for managing adverse effects. GSK’s Tony Wood emphasized Blenrep’s role as the only anti-BCMA therapy accessible in community settings, where most myeloma care occurs.
While Blenrep rejoins a crowded field of myeloma therapies, its demonstrated efficacy and new approval may provide important hope for patients with relapsed disease who have exhausted other options.
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