National Medical Products Administration has approved belantamab mafodotin with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma after at least one prior therapy.
The approval is based on the DREAMM-7 trial, where the combination significantly outperformed a standard daratumumab-based regimen. It extended progression-free survival to 36.6 months versus 13.4 months and reduced the risk of death by 42%, with a three-year survival rate of 74% compared to 60%.
Benefits were consistent even in high-risk and treatment-resistant patients. Common side effects included thrombocytopenia and diarrhea, while eye-related effects were manageable and rarely led to discontinuation.
As an anti-BCMA therapy, it can be given in outpatient settings without complex preparation. This follows a similar approval by the U.S. Food and Drug Administration in 2025.