2 multiple myeloma treatments receive FDA approval

Multiple myeloma affects more than 36,000 patients each year in the United States and is the second-most common blood cancer in adults.

When it develops, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells.

Instead of making useful antibodies that can help the body fight infections, the cancer cells make abnormal proteins, causing bone and kidney damage.

Most people diagnosed with multiple myeloma are at least 65 years old and the disease is more than twice as common in African Americans than in other groups.

In addition to the active disease, multiple myeloma can also have precursor conditions, which are called smoldering multiple myeloma and monoclonal gammopathy of undetermined significance.

Both conditions require monitoring since they can evolve into blood cancer.

In 2025, the Food and Drug Administration approved two drugs—daratumumab and linvoseltamab—for precursor conditions to multiple myeloma and relapsed multiple myeloma.

Matthew Pianko, Clinical Associate Professor of Internal Medicine and member of Rogel Cancer Center, answers questions about the current treatment options for multiple myeloma, the new FDA-approved drugs and what these treatments mean for patients.

How do precursor conditions for multiple myeloma develop?

Pianko: Although it is not well understood, precursor states can sometimes begin in patients when at age 30 or older.

We think that there are genetic changes that accumulate in plasma cells over a person's lifetime that might turn them into cancerous cells.

There's currently no screening program in the U.S. to identify patients with precursor conditions to multiple myeloma.

They are often found by accident when evaluating patients for other medical issues or in response to abnormal laboratory tests that are found through routine follow up with primary care physicians or other medical providers.

Patients who develop active myeloma at some point in time had a precursor state, whether it was known or not.

What are the current treatment options?

Pianko: Researchers have been developing new therapies which help T cells attack multiple myeloma.

This has been done by creating antibodies that engage the T cells and attach to specific proteins unique to myeloma cells.

There are two types of antibodies: monoclonal that binds to a specific target and bispecific that binds to two different targets at the same time. Both redirect the immune system to attack cancer cells.

We participated in a clinical trial for patients with high risk smoldering multiple myeloma.

This led to the FDA approval of daratumumab, a monoclonal antibody drug, which targets CD38 proteins on cancer cells.

Linvoseltamab, which is a bispecific antibody for treating relapsed multiple myeloma, recognizes a protein called BCMA on the surface of multiple myeloma cells.

Our participation in linvoseltamab trials led to its FDA approval in collaboration with other investigators around the world.

What does the FDA approval mean for patients?

Pianko: Treatment of precursor states in multiple myeloma is a complex topic that has a lot of nuance.

Many patients with precursor conditions will never develop active myeloma, and we need to evaluate an individual person's risk and history.

I encourage patients with precursor conditions to talk with their treating physician and determine if these medications or new clinical trials are appropriate.

For example, linvoseltamab is being studied as a treatment approach for patients with precursor conditions who may have a high lifetime risk of developing myeloma but who do not carry an immediately high risk type.

What future directions are you working on?

Pianko: We can develop better ways to help classify patients with precursor conditions based on a variety of factors, including the amount of abnormal plasma cells they have and the amount of abnormal protein that those cells make.

We can also use genetic tools to understand whether a patient has a precursor condition that is biologically predisposed towards developing active myeloma or if they have a genetic signature that is associated with a lower risk precursor condition.

To date, myeloma is not considered to be a curable disease. However, as patients have responses that last longer, we're hopeful that advances in immune therapies could potentially lead to curative treatment in the future.

Disclosure(s): Matthew Pianko: Bristol-Myers Squibb Company; GlaxoSmithKline; Johnson & Johnson

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