The U.S. Food and Drug Administration (FDA) has approved the combination of teclistamab-cqyv (Tecvayli) plus daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with relapsed or refractory multiple myeloma who have already had at least one line of treatment. Prior lines need to have included a proteasome inhibitor and an immunomodulatory agent.

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In the phase 3 trial, the combo was linked to an 83 percent reduction in the risk of disease progression or death compared with standard treatment regimens.

For people living with multiple myeloma, this approval may offer a new treatment option earlier in care after relapse.

How Does the Drug Combo Work?

This newly approved treatment combines two medicines:

• Teclistamab-cqyv — A type of immunotherapy called a bispecific T-cell engager
• Daratumumab and hyaluronidase-fihj — A CD38-directed antibody given as an injection under the skin

These drugs are designed to work together to help the immune system find and attack myeloma cells that express B-cell maturation antigen (BCMA). Teclistamab targets BCMA and CD3, while daratumumab targets CD38.

Teclistamab-cqyv works by attaching to two targets at once. One target is CD3 on T cells, a type of immune cell that can destroy cancer cells. The other is BCMA, a protein on multiple myeloma cells. The drug brings T cells into contact with cancer cells so the immune system can attack them.

Daratumumab and hyaluronidase-fihj works by targeting CD38, a protein plentiful on multiple myeloma cells.

What Did Clinical Trials Show?

The approval was based on results from an ongoing phase 3 study. The study compared teclistamab plus daratumumab with other daratumumab-based treatment combinations in people with relapsed or refractory multiple myeloma who had already received at least one prior treatment.

After a median follow-up of three years, the combination of teclistamab plus daratumumab showed better outcomes than the comparison treatments.

People taking the combination had:

• An 83 percent lower risk of disease progression or death
• A three-year progression-free survival rate of 83 percent, compared with 30 percent in the comparison group
• A three-year overall survival rate of 83.3 percent, compared with 65 percent in the comparison group

The combination led to higher rates of response. At three years:

• 89 percent of people had an overall response, compared with 75.3 percent in the comparison group
• 81.8 percent had a complete response or better, compared with 32.1 percent

What Side Effects Were Reported?

Like all cancer treatments, this combo can cause side effects. Some are more common, while others happen in only a few people. In studies, commonly reported side effects included:

• Infections (such as upper respiratory infections and pneumonia)
• Cough
• Diarrhea
• Muscle or bone pain
• Fatigue
• Fever
• Headache
• Nausea
• Reactions at the injection site

Some side effects can be serious. These include severe infections and critically low blood cell counts, as well as immune-related reactions like cytokine release syndrome (CRS). CRS may cause fever, chills, or breathing problems.

A rare but serious risk is neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), which can affect the brain and nerves. Other risks may include liver problems and allergic or injection-related reactions.

Because of these risks, people taking this drug combo require close monitoring.

What This Means for People With Multiple Myeloma

Because multiple myeloma usually comes back after treatment, many people need new options over time. This approval gives some people with relapsed multiple myeloma access to a newer immune-based treatment after just one prior line of therapy.

Although the results are encouraging, this treatment may not be right for everyone. Treatment decisions can depend on many factors, including your past treatments, overall health, side effect risks, and personal preferences. Work together with your oncologist to choose the treatment plan that best fits your needs and goals.

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On MyMyelomaTeam, people share their experiences with multiple myeloma, get advice, and find support.

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