What is the current status of belantamab and its potential reapproval? (https://www.myeloma.org/videos/current-status-belantamab-its-potential-reapproval)
Belantamab Status and Potential Reapproval
In this week's Ask Dr. Durie, IMF Chief Scientific Officer and multiple myeloma expert Dr. Brian G.M. Durie discusses the current status of belantamab, an anti-BCMA drug conjugate, which had its FDA approval withdrawn but shows promise for reapproval based on recent trial data.
The Bottom Line: It's too soon to know what the follow-through will be. However, the data from the DREAMM-8, as well as DREAMM-6 and other trial data, will need to be submitted to the FDA for regulatory assessment.
However, it is good news that the belantamab can potentially be reactivated and potentially again be re-approved by the FDA and the United States as part of this Pomalidomide-dexamethasone combination. So we need to stay alert and see what is the follow-through with these recent important trials.
This week's Ask Dr. Durie comes from a patient who wants to know whatever happened to belantamab? Belantamab is an anti-BCMA drug conjugate, which was approved in the United States, but that approval was withdrawn when a post-approval trial failed to meet its statistical endpoint.
However, additional trials have been ongoing and the results of a DREAMM-8 trial were presented at the ASCO meeting 2024. In this trial, belantamab, the anti-BCMA drug conjugate combined with Pomalidomide and dex was compared with Pomalidomide, Velcade and Dex. And the results were very, very good in that the progression-free survival and the overall response rate were superior with the belantamab combination.
What has been a concern is the eye toxicity. However, the eye side effects with the combination as administered as part of the DREAMM-8 were manageable and acceptable. And so, this was really good news for the potential re-approval of belantamab.
The bottom line here is that it's too soon to know what the follow-through can be. However, the data from the DREAMM-8, as well as some additional trial data follow on from DREAMM-6 and other trial data will need to be submitted to the FDA for regulatory assessment.
However, it is good news that the belantamab can potentially be reactivated and potentially again be re-approved by the FDA and the United States as part of this Pomalidomide-dexamethasone combination. So we need to stay alert and see what is the follow-through with these recent important trials.
Dr. Brian G.M. Durie (1942-2025) was the co-founder of the IMF. He was a Professor of Medicine, Hematologist/Oncologist, and Honoree MD at the University of Brussels.