FDA Approves Teclistamab Combo for Relapsed/Refractory Multiple Myeloma

New treatment option offers improved progression-free and overall survival rates

Mar. 8, 2026 at 1:04pm

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The Food and Drug Administration has approved teclistamab-cqyv in combination with daratumumab hyaluronidase-fihj for adults battling relapsed or refractory multiple myeloma, offering a new treatment option for patients who have already undergone at least one prior line of therapy.

Why it matters

This approval expands the use of teclistamab as a standalone treatment for those who have experienced relapse after at least four previous therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. The combination therapy has shown significant improvements in progression-free survival and overall survival rates compared to standard care regimens.

The details

The FDA's decision is based on data from the phase 3 MajesTEC-3 trial, which demonstrated an 83% reduction in the risk of disease progression or death compared to standard care regimens. Patients receiving the teclistamab-daratumumab combination exhibited a 3-year PFS rate of 83.4% and a 3-year overall survival rate of 83.3%, substantial improvements over the control group.

  • The FDA approval was announced on March 8, 2026.

The players

Teclistamab-cqyv

A bispecific antibody that targets a protein on myeloma cells and a target on immune cells, enhancing the immune system's ability to attack cancer cells.

Daratumumab hyaluronidase-fihj

An antibody that targets a protein called CD38 on myeloma cells.

Luciano J. Costa, MD

Professor of multiple myeloma and director of the multiple myeloma research and treatment program at the University of Alabama at Birmingham.

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What they’re saying

“This new treatment option can redefine how we approach [relapsed or refractory multiple myeloma] treatment by giving health care providers a regimen with improvement in PFS and OS and a well-characterized safety profile.”

— Luciano J. Costa, MD, Professor of multiple myeloma and director of the multiple myeloma research and treatment program at the University of Alabama at Birmingham

What’s next

Researchers and healthcare providers will continue to explore the potential of combination therapies, including teclistamab and daratumumab, to further improve outcomes for patients with relapsed or refractory multiple myeloma.

The takeaway

The approval of this teclistamab-daratumumab combination represents a significant advancement in the treatment of relapsed or refractory multiple myeloma, offering patients a new option with improved progression-free and overall survival rates.