U.S. FDA Approves Teclistamab (Tecvayli) with Daratumumab (Darzalex Faspro) for Relapsed or Refractory Multiple Myeloma

On March 5, 2026, the U.S. Food and Drug Administration (FDA) approved teclistamab (Tecvayli, Johnson & Johnson) in combination with daratumumab hyaluronidase-fihj (Darzalex Faspro, Johnson & Johnson). It is approved for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory medicine.

Multiple myeloma is a cancer that forms in plasma cells, a type of white blood cell found in the bone marrow. Although treatments for myeloma have improved over the past decade, the cancer can return after therapy and treatments can stop working to control the cancer. When this happens, each new treatment may work for a shorter period of time. Because of this, there is still a need for therapies that can control myeloma longer and help patients experience deeper responses. 

Teclistamab is an immune-based treatment called a bispecific antibody. It was first approved in 2022 as a single therapy for people with heavily treated myeloma. The new FDA decision allows teclistamab to be used earlier in treatment when combined with daratumumab. At the same time, the FDA also converted teclistamab’s earlier accelerated approval as a single therapy into full traditional approval based on new clinical trial results. 

“The FDA is now proactively moving to cut idle time to accelerate meaningful treatments for the American people. Multiple myeloma is notoriously challenging to treat. When we saw the most impressive second-line myeloma trial results in history, we acted quickly to bring this finding to everyday Americans wrestling with the disease.”-- FDA Commissioner Marty Makary, M.D., M.P.H. in a press release

How does teclistamab with daratumumab treat myeloma?

Bispecific antibodies connect two different types of cells. Teclistamab binds to BCMA, a protein found on myeloma cells, and CD3, a protein on immune T cells. By bringing these cells together, teclistamab helps T cells recognize and remove myeloma cells. 

Daratumumab is a monoclonal antibody. It targets the CD38 protein on myeloma cells. It also helps the immune system identify and remove cancer cells. When used together, these immunotherapies activate the immune system in different ways to help treat myeloma. 

Teclistamab and daratumumab are both given as injections under the skin. Treatment begins with step-up doses of teclistamab during the first week. This helps reduce the risk of immune-related side effects, followed by regular treatment doses that may be given weekly at first and then less often over time. Daratumumab is given on its standard schedule, typically once weekly at the beginning of treatment, then every two weeks, and later once every four weeks as treatment continues. 

The study that led to teclistamab with daratumumab’s  approval

The approval was based on results from the phase 3 MajesTEC-3 clinical trial (NCT05083169). The study included 587 patients with relapsed or refractory multiple myeloma who had received one to three prior treatments.

Participants were randomly assigned to receive either the teclistamab and daratumumab combination or one of two standard treatments: daratumumab, pomalidomide, and dexamethasone, or daratumumab, bortezomib, and dexamethasone.

The results showed strong improvements with the teclistamab combination. After almost 3 years of follow-up, the median progression-free survival was not reached for patients who received teclistamab and daratumumab. In comparison, the median progression-free survival for patients who received standard therapy was 18.1 months. 

Read a more detailed report about how the combination worked in this article: Immunotherapy Combination Teclistamab Plus Daratumumab Lowers Risk of Death for People with Relapsed/Refractory Multiple Myeloma 

What are the common side effects of teclistamab with daratumumab?

The most common side effects of teclistamab with daratumumab for people with myeloma are:

• Cytokine release syndrome (CRS)
• Low antibody levels (hypogammaglobulinemia)
• Upper respiratory infection
• Cough
• Diarrhea
• Muscle or bone pain
• COVID-19
• Pneumonia
• Injection-site reactions
• Fatigue
• Fever
• Headache
• Nausea
• Stomach flu
• Weight loss

During the clinical trial, fewer than 4.6% of patients stopped treatment due to side effects. 

Next steps for people living with myeloma

If you or a loved one has myeloma, ask your healthcare team about how your current treatment is working for you and if teclistamab with daratumumab or ongoing studies may be right for you. 

Questions to ask your care team about teclistamab with daratumumab 

Consider asking your care team the following questions about teclistamab with daratumumab:

• Am I eligible for teclistamab with daratumumab?
• What side effects should I expect with this treatment?
• How often will I receive the injections?
• How does this therapy compare with my other treatment options?
• Are there clinical trials studying similar immunotherapy combinations?

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Sources: 

• FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma
• FDA Grants Third Approval Under the National Priority Voucher Program
• Phase 3 randomized study of teclistamab plus daratumumab versus investigator’s choice of daratumumab and dexamethasone with either pomalidomide or Bortezomib (DPd/DVd) in patients (Pts) with relapsed refractory multiple myeloma (RRMM): Results of majestec-3
• MajesTec-3 Study Protocol: Tec-Dara SC Dosing