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On November 22, 2022, it was announced that the process for the withdrawal of the US marketing authorization for belantamab mafodotin has been initiated.1 Discussions with European Union health authorities are still ongoing and no official decision has been shared yet.1
Belantamab mafodotin is a monotherapeutic agent that previously received U.S. Food and Drug Administration (FDA) accelerated approval for the treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
This withdrawal is based on results of the DREAMM-3 trial (NCT04162210), in which the primary endpoint of progression-free survival was not met, with a hazard ratio of 1.03 (95% confidence interval, 0.72–1.47) in a head-to-head comparison of belantamab mafodotin versus pomalidomide plus dexamethasone.2 A longer observed median progression-free survival of 11.2 months was seen with belantamab mafodotin, compared with 7 months for pomalidomide plus dexamethasone.2
The safety and tolerability profile of belantamab mafodotin was consistent with the established safety profile, with no new safety concerns.2
Patients already receiving belantamab mafodotin and enrolled on the FDA Risk Evaluation and Mitigation Strategy (REMS) program will be able to continue to receive the drug through a compassionate use program.3
Clinical trials with belantamab mafodotin are ongoing, with data from the DREAMM-7 and DREAMM-8 phase III clinical trials expected in 2023.2,3
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