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Belantamab mafodotin combinations approved in Japan for the treatment of RRMM

By Jen Wyatt Green

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May 20, 2025

Learning objective: After reading this article, learners will be able to cite a new clinical development in multiple myeloma.


On May 19, 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) announced the approval of belantamab mafodotin combinations for the treatment of adults with relapsed/refractory multiple myeloma (RRMM).1

The approval is based on results from the phase III DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) trials evaluating belantamab mafodotin in combination with bortezomib plus dexamethasone (BVd) and in combination with pomalidomide plus dexamethasone (BPd), respectively, in patients with MM who have received ≥1 prior therapy. 1

The approval follows an orphan drug designation for belantamab mafodotin in Japan, granted based on its ability to address the high unmet need for patients with MM. Belantamab mafodotin combinations are currently under review globally.1

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