European Union Approves Linvoseltamab for Relapsed/Refractory Multiple Myeloma

On April 28th 2025, Regeneron announced that linvoseltamab (Lynozyfic) received conditional approval from the European Commission to treat relapsed and refractory multiple myeloma. This approval is for people who have received at least three prior treatments, including a proteasome inhibitor, an immunomodulatory therapy, and an anti-CD38 antibody.

Linvoseltamab is a bispecific antibody that acts by linking a marker on myeloma cells called BCMA to T-cells. This helps the immune system identify and eliminate myeloma cells.

The Study that Accelerated Linvoseltamab’s Approval

The approval was based on a clinical study called LINKER-MM1 that included 117 patients who took linvoseltamab. The results showed:

• 71% of patients responded to the therapy
• 50% achieved a complete response or better
• 41% of those with complete responses had minimal residual disease (MRD) negativity
• The median duration of response was 29 months

These outcomes are significant because they show the potential for deep and lasting responses in patients who have already been through several other treatments. This could mean longer periods without active disease for some individuals.

Read more about the LINKER-MM1 study here: 

• A New BCMA-Targeting Bi-specific Antibody, Linvoseltamab
• Promising Results of Linvoseltamab in Relapsed/Refractory Myeloma: LINKER-MM1 Study

What’s Next in the U.S.?

In the U.S., the Food and Drug Administration is reviewing the therapy, with a decision expected by July 10, 2025. We anticipate covering the future outcome. 

Linvoseltamab is still being studied in other clinical trials. These studies explore whether it can be used earlier in the course of the disease, on its own, or in combination with other therapies. 

Click Here to Explore the Ongoing Trials with Linvoseltamab

Flexible and Less Frequent Dosing Over Time

Linvoseltamab’s dosing schedule is based on how well a patient responds to treatment. It begins with a "step-up" phase to reduce the chance of certain side effects, during which patients stay near a treatment center for safety monitoring. After this initial phase:

• The therapy is given weekly, then every two weeks.
• If patients achieve a very good partial response or better after 24 weeks, the therapy can be spaced out to once every four weeks.

This response-adapted dosing is meant to balance effectiveness with convenience. For patients, fewer clinic visits may ease the treatment burden, especially if their myeloma is responding well.

In the study, the most common side effects included:

• Muscle and joint pain (52%)
• Cytokine release syndrome (CRS) (46%) most cases were mild to moderate and resolved within a day
• Low white blood cell counts (43%)
• Cough, diarrhea, anemia, and fatigue (30–42%)
• Infections such as pneumonia (32%)

The Importance of this Approval for Myeloma Patients

For people with limited options who have tried multiple therapies in the past, a treatment that offers deep responses and a flexible dosing schedule can make a meaningful difference in treatment planning and quality of life.

Patients considering this therapy should talk with their healthcare team about whether it is right for them, based on their previous treatments and current health status.

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Source: 

• Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma