FDA Reviews Belantamab Mafodotin for Approval in Relapsed/Refractory Multiple Myeloma

Promising news for relapsed and refractory now that the U.S. Food and Drug Administration (FDA) is reviewing a Biologics License Application (BLA) for belantamab mafodotin in combination with other therapies such as bortezomib and dexamethasone, and pomalidomide with dexamethasone. If approved, this new treatment option could significantly impact patients who have received at least one prior therapy, with a final decision expected by July 23, 2025.

Why Is This Action Important?

Multiple myeloma is the third most common blood cancer globally. While treatment advancements have improved outcomes, for some high-risk patients, existing therapies are not enough to address their therapeutic goals. Highlighting the need for effective, tolerable, and accessible treatments.

Belantamab mafodotin was initially approved for multiple myeloma but after the results of the DREAMM-3 trial, where it needed more data to meet the expected endpoint (which was an improvement in progression-free survival), it was taken off the market in 2022.

Further research has shown potential for treating relapsed and refractory multiple myeloma, supported by the results from DREAMM-7 and DREAMM-8 phase III trials. These trials demonstrated improvements in progression-free survival (PFS) and, in one trial, overall survival (OS)—two key measures of a treatment’s success.

A Transformative Opportunity

If approved, belantamab mafodotin could expand the treatment options for relapsed or refractory multiple myeloma patients. The medication’s ability to be administered in community settings, along with predictable side effects, would also improve accessibility and quality of life.

What Makes Belantamab Mafodotin Unique?

Belantamab mafodotin is designed to target B-cell maturation antigen (BCMA), a protein commonly found on multiple myeloma cells. This allows it to directly target cancer cells while sparing healthy cells.

This innovative approach positions belantamab mandolin as a potential game-changer for patients, especially those whose disease has become resistant to other treatments.

What Do I Need to Know About the DREAMM-7 and DREAMM-8 Trials?

We have an in-depth article on the latest results presented at ASCO 2024 on these two trials, which you can review here. 

DREAMM-7 Trial 

• Included 494 patients with relapsed/refractory multiple myeloma who had received at least one prior therapy.

• Used belantamab mafodotin with bortezomib/dexamethasone versus daratumumab with bortezomib/dexamethasone.

DREAMM-8 Trial 

• Included 302 patients with relapsed/refractory multiple myeloma who had received more prior treatments, including lenalidomide.

• Featured belantamab mafodotin with pomalidomide and dexamethasone versus bortezomib with pomalidomide and dexamethasone.

Global Impact On Myeloma

The FDA's review marks the sixth regulatory filing acceptance this year for belantamab mafodotin combinations. Regulatory bodies in the European Union, Japan, Canada, Switzerland, and China are also evaluating the treatment, remarking on its global importance.

For the approximately 35,000 patients in the U.S. expected to be diagnosed with multiple myeloma in 2024, and others already diagnosed with relapsed or refractory disease, the approval of belantamab mafodotin could expand their options and provide improved quality of life.

Next Steps

The FDA decision is expected by July 23, 2025, and stay tuned to learn more, since HealthTree will be covering myeloma highlights at the 66th American Society of Hematology (ASH) Annual Meeting taking place on 5-9th December 2024, where additional data, including survival outcomes from the DREAMM-7 trial, will be presented. 

If you also want to contribute to patient-focused research, or keep learning more about multiple myeloma, create a free HealthTree account. You can access different surveys, keep track of your disease, and use all of our amazing free resources! 

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Sources: 

• Belantamab mafodotin combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma

• Belantamab for myeloma: ASCO 2024 DREAMM trials presented data 

• What GSK's BLENREP Change Means for US Myeloma Patients