Tecvayli (teclistamab-cqyv) for multiple myeloma

Written by Lila Levinson, PhD | Last updated March 11, 2026
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What is Tecvayli for multiple myeloma?

Tecvayli (teclistamab-cqyv) is an antibody-based therapy approved for certain adults with multiple myeloma that has returned after prior therapies (relapsed) or is proven resistant to treatment (refractory). It can be used as a standalone treatment or in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj), another approved myeloma therapy.

Multiple myeloma occurs when plasma cells, a type of immune cell, become cancerous and start growing out of control in the bone marrow, the spongy interior of some bones where blood cells are produced.

Tecvayli aims to help the immune system more efficiently target and kill cancerous plasma cells (myeloma cells). It is a bispecific antibody that simultaneously recognizes and binds to two proteins. One of those proteins is CD3, which is found on the surface of immune T-cells, and the other is B-cell maturation antigen, which is found on the surface of plasma cells, including myeloma cells. This dual binding activates T-cells, which can kill cancer cells, and directly connects them to the myeloma cells they need to destroy. In some patients, this can help control multiple myeloma.

Johnson & Johnson (J&J) markets Tecvayli, which is administered via under-the-skin (subcutaneous) injections. 

Therapy snapshot

Brand name  Tecvayli
Chemical name Teclistamab-cqyv
Usage  Used to treat certain adults with relapsed or refractory multiple myeloma
Administration Subcutaneous injection

Who can take Tecvayli?

In the U.S., Tecvayli is approved for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) when used:

  • with Darzalex Faspro in patients who have previously received at least one prior line of treatment, including an immunomodulatory drug and a proteasome inhibitor
  • as a single therapy in patients who have previously received at least four lines of treatment, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody

There are no listed contraindications or reasons to avoid using Tecvayli. However, the therapy’s prescribing information comes with a boxed warning for potentially life-threatening complications, including inflammatory responses and neurological conditions. For this reason, Tecvayli is only available in the U.S. through a restricted distribution program called the Tecvayli and Talvey Risk Evaluation and Mitigation Strategy.

How is Tecvayli administered?

A healthcare professional administers Tecvayli in a hospital setting as a subcutaneous injection. Usually, the injection is given into the abdomen, but it can also be given into the thigh or other parts of the body.

Patients starting treatment with Tecvayli as a single therapy or in combination with Darzalex Faspro usually follow a step-up dosing schedule that features three increasing doses of Tecvayli over one week, with the third dose being the first full dose (1.5 mg/kg). Before each step-up dose and the first full dose, those given the therapy will receive medications to reduce the risks of potential side effects. After each injection, patients typically stay in the hospital for two days to allow doctors to monitor them for signs of serious side effects.

After the step-up period, Tecvayli is usually given until disease progression or unacceptable toxicity. The precise dosing regimen depends on the usage:

  • When used in combination with Darzalex Faspro, Tecvayli is given at a dose of 1.5 mg/kg once weekly for weeks 2-8, then every two weeks at a dose of 3 mg/kg for weeks 9-24, and then every four weeks at a dose of 3 mg/kg from week 25 onward.
  • When used as a single therapy, Tecvayli is given at a dose of 1.5 mg/kg once weekly; dosing frequency may be reduced to once every two weeks if patients respond to treatment (achieve a complete response or better) and continue responding for at least six months.

Tecvayli in clinical trials

Tecvayli’s approval in the U.S. as a single therapy, or monotherapy, was supported by data from the MajesTEC-1 clinical trial, which included a Phase 1/2 portion (NCT03145181) to establish the medication’s recommended dose. A Phase 2 portion (NCT04557098) then assessed the safety and effectiveness of that dose in a larger patient population. The study enrolled RRMM patients who had previously received at least three lines of therapy.

  • The Phase 1/2 portion of the study established a dose of 1.5 mg/kg after the step-up period, which is now the approved full dose, for the Phase 2 portion.
  • Among the subset of 110 patients who comprised the study’s Phase 2 efficacy population, approximately 62% had at least a partial response to treatment. Follow-up data showed that treatment responses were maintained in the long term.

Tecvayli’s approval as part of the combination treatment regimen with Darzalex Faspro was supported by data from another clinical trial, called MajesTEC-3 (NCT05083169). That Phase 3 trial involved RRMM patients who had previously received one to three lines of therapy. Study data showed that the combination of Tecvayli and Darzalex Faspro:

  • significantly extended the time patients lived without disease progression compared with standard-of-care regimens
  • led to higher rates of complete and overall treatment responses compared with other regimens

Other ongoing studies have suggested that Tecvayli is also effective in different RRMM settings:

Tecvayli side effects

The most common side effects of Tecvayli in patients given the medication as a standalone treatment include:

  • fever
  • cytokine release syndrome
  • musculoskeletal pain
  • injection site reactions
  • fatigue
  • upper respiratory tract infections
  • nausea
  • headache
  • pneumonia
  • diarrhea

For those receiving the therapy as part of a combination with Darzalex Faspro, the most common side effects of Tecvayli treatment include:

  • low immunoglobulin (antibody) levels
  • upper respiratory tract infections
  • cytokine release syndrome
  • cough
  • diarrhea
  • musculoskeletal pain
  • COVID-19
  • pneumonia
  • injection site reactions
  • fatigue
  • fever
  • headache
  • nausea
  • stomach and intestinal inflammation
  • weight loss

It is also common for people taking Tecvayli to experience decreases in blood cell counts.

The boxed warning for Tecvayli notes that cytokine release syndrome (CRS), a type of systemic inflammatory response, can occur and be life-threatening or fatal in people taking the medication. However, the therapy’s step-up dosing schedule may help reduce this risk. Serious and potentially life-threatening neurological complications, including immune effector cell-associated neurotoxicity syndrome, have also been linked to Tecvayli. Treatment may have to be paused or permanently discontinued if CRS or neurological complications occur.

Other potentially serious side effects of Tecvayli include:

  • liver toxicity
  • severe, life-threatening, or fatal infections
  • dangerously low neutrophil counts, which can increase the risk of infections
  • allergic reactions

Tecvayli may cause fetal harm if administered during pregnancy. It is recommended that females of reproductive potential use an effective method of contraception to avoid pregnancy during treatment and for at least five months after their last dose.

Rare Cancer News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.


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