Oncology/Hematology
>
Myeloma
— Blenrep once again indicated for relapsed or refractory multiple myeloma
by Mike Bassett, Staff Writer, MedPage Today
October 23, 2025 • 2 min read
The FDA has once again approved belantamab mafodotin (Blenrep) for multiple myeloma, 3 years after the drug left the market over questions about its efficacy.
A B-cell maturation antigen (BCMA)-targeted agent, belantamab mafodotin is now indicated in combination with bortezomib (Velcade) and dexamethasone (BVd) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug.
The new approval comes despite various concerns raised by an FDA advisory committee in July, including ocular toxicities. The committee ultimately voted that the risks with the BCMA-targeted agent outweighed the benefits for two proposed indications.
The ocular toxicity issue earned belantamab mafodotin a risk evaluation and mitigation strategy from FDA.
Approval was supported by data from DREAMM-7, a phase III trial in which patients treated with BVd had significantly improved progression-free and overall survival versus those who received a combination of daratumumab (Darzalex) plus bortezomib and dexamethasone.
“With the approval of Blenrep we now have a community-accessible BCMA-targeting agent with the potential to improve outcomes for patients following two or more prior lines of treatment, where options are limited. This approval marks an important advance in the U.S. relapsed/refractory treatment landscape,” said Sagar Lonial, MD, of the Winship Cancer Institute of Emory University in Atlanta, in a press release from drugmaker GSK.
It’s been a roller coaster ride for the drug ever since it was granted accelerated approval in 2020 for the treatment of relapsed or refractory myeloma after at least four prior therapies. Two years later, belantamab mafodotin was pulled from the market after the DREAMM-3 confirmatory trial failed to meet its primary endpoint.
With additional data showing belantamab’s efficacy in DREAMM-7 and DREAMM-8 — which evaluated belantamab mafodotin in combination with pomalidomide (Pomalyst) and dexamethasone (BPd) after at least one prior line of therapy, including lenalidomide (Revlimid) — the drug went back to the FDA for review.
While the BCMA-targeted agent was approved as part of the BVd combination, it failed to pass muster with the agency in the BPd combination.
Prescribing information includes a boxed warning for the risk of ocular toxicity, including corneal epithelium changes resulting in vision deterioration. In DREAMM-7, ocular toxicity occurred in 92% of patients (grade 3/4 in 77%), with 83% requiring dose modification due to the side effect.
Other warnings and precautions include thrombocytopenia and embryo-fetal toxicity.
