News|Videos|October 29, 2025

What to Know About the FDA Approval of Blenrep for Multiple Myeloma

Author(s)Alex Biese
Fact checked by: Spencer Feldman

The FDA has approved Blenrep with BVd as a third-line treatment for relapsed or refractory multiple myeloma.

The U.S. Food and Drug Adminsitration (FDA) has approved Blenrep (belantamab mafodotin-blmf) in combination with Velcade (bortezomib) and dexamethasone (a combination known as BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.

To discuss this approval and its significance for patients, CURE spoke with Dr. Surbhi Sidana, who is the chair of the American Society of Hematology’s Committee on Communications and an associate professor of medicine at Stanford University in California.

Transcript

What do patients need to know about the FDA’s recent approval of Blenrep for relapsed or refractory multiple myeloma?

So Blenrep or belantamab mafodotin, for those who don't know, is an antibody-drug conjugate that targets BCMA. It is given typically every three weeks, and it can be given in the community centers, unlike other BCMA-targeted therapies that are on the market, like CAR-T cell therapy and bispecific antibodies that require a little more of a resource-intense setting to give. So, one significance is that for patients who truly cannot access CAR-T cell therapy or cannot access bispecific antibodies because of where they live, this provides a very effective option for BCMA-targeted therapy that was not previously available to them. The tolerability and side effect profile is also different — so that gives, again, patients other options. As you know, patients with multiple myeloma, for the vast majority of patients, they are not cured. Maybe some patients are getting into long-term disease control with CAR-T without any [subsequent] therapy. And certainly, we have many effective options, but patients do relapse, and they require several lines of therapy. So, this [approval by the FDA] adds yet another highly effective option for our patients, and then the requirements of where it can be given are slightly different. So again, every patient's priorities are different, and so this gives an option for patients who choose to get a different BCMA[-targeted] option.

Transcript has been edited for clarity and conciseness.

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