Belantamab mafodotin (BLENREP), developed by GSK, is the first and only approved B-cell maturation antigen (BCMA)-targeting antibody-drug conjugate (ADC) for multiple myeloma, offering a readily accessible, off-the-shelf treatment option for patients with relapsed or refractory disease. Its simple outpatient administration and accessibility in community practice settings differentiate it from more complex BCMA-directed therapies, supporting broader patient access across treatment settings.

In October 2025, the US FDA approved belantamab mafodotin in combination with bortezomib and dexamethasone (BVd) for adults with RRMM who had received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Subsequently, in April 2026, China's NMPA approved the same regimen for patients who had received at least one prior line of therapy, based on positive results from the Phase III DREAMM-7 trial. 

GSK is advancing belantamab mafodotin into earlier treatment settings, including the Phase I DREAMM-9 study evaluating its combination with VRd in transplant-ineligible newly diagnosed multiple myeloma. At ASCO 2026, the final analysis of DREAMM-9 demonstrated that BVRd achieved deep and durable responses in this population, supporting its potential as a novel frontline treatment option.

Key Highlights:

KOL insights

“With only about one-fourth of the global multiple myeloma population currently able to access T-cell–redirecting therapies, a substantial unmet need remains. Easily accessible BCMA-directed therapies could help bridge this gap, particularly for older patients and those in healthcare settings where cellular therapies are not readily available."–Expert Opinion

“Belantamab’s unique mechanism as an antibody-drug conjugate allows for convenient off-the-shelf use, making it particularly appealing in community settings. While ocular toxicity remains a concern, emerging data suggest that these events are largely reversible, manageable with dose modifications, and may be reduced with optimized dosing schedules.” –Expert Opinion

Conclusion

According to DelveInsight estimates, approximately 21,850 first-line transplant-ineligible multiple myeloma cases were diagnosed in the United States in 2025, representing a substantial patient population with ongoing unmet clinical needs. The majority of newly diagnosed multiple myeloma patients are considered ineligible for ASCT because the disease primarily affects older adults, with a median diagnosis age of around 70 years. Many patients also have comorbid conditions or reduced physical fitness, which make them less suitable for intensive treatments such as high-dose chemotherapy with Melphalan that precedes transplantation. In frontline multiple myeloma daratumumab (DARZALEX) was successful and is now considered standard of therapy. 

The DREAMM-9 findings indicate that optimizing the dosing schedule of BLENREP may enable a more favorable balance between efficacy and tolerability, addressing a key historical limitation of BCMA-directed ADC therapy. Collectively, these data support Belantamab’s potential to expand into earlier lines of treatment and reinforce its role as a readily accessible BCMA-targeted option with the ability to broaden treatment access beyond specialized centers.