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Is Tecvayli FDA approved as a multiple myeloma treatment?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Dec 13, 2022.

Official answer


Yes, Tecvayli received accelerated approval by the FDA in October 2022 to treat adults with multiple myeloma (cancer of cells in bone marrow) that has come back or failed previous treatment. Patients eligible for Tecvayli have a high unmet need for treatment, as they have received at least 4 prior lines of cancer therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

Tecvayli (generic name: teclistamab-cqyv) is manufactured by Janssen Pharmaceuticals. It is available only through a restricted program called the Tecvayli REMS (Risk Evaluation and Mitigation Strategy) due to the risk of serious side effects: Cytokine Release Syndrome (CRS) and neurologic problems.

What is Tecvayli and how does it work?

Tecvayli is classified as a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. BCMA is a protein that is found in high levels on multiple myeloma cancer cells. Tecvayli works by activating the immune system by redirecting CD3-positive T-cells (a type of white blood cell) to BCMA-expressing myeloma cells leading to cancer cell death.

How well does Tecavyli work in multiple myeloma?

Janssen submitted the Phase 2 MajesTEC-1 study to the FDA for approval of Tecvayli. This study included 110 heavily pretreated patients with advanced multiple myeloma who had received a median of 5 prior lines of therapy.

Researchers evaluated the overall response rate and complete response rate, as well as response times. Overall response rate is defined as the number of patients in a study whose tumor is destroyed (complete response) or significantly reduced (partial response) by a drug. Complete response does not always mean the cancer has been cured.

  • In this study, an overall response rate (ORR) of 61.8% (95%CI: 52.1 to 70.9%) was achieved. In addition, 28.2% of patients achieved a complete response or better.
  • The median time to first response was 1.2 months (range 0.2 to 5.5 months), and the estimated duration of response was 90.6% at 6 months and 66.5% at 9 months.

The most common side effects (>20%) in the safety population of MajesTEC-1 (n=165) were pyrexia (fever), CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.

Tecvayli also carries a Boxed Warning for Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), which can be fatal.

Related: Tecvayli Precautions and Side Effects

This is not all the information you need to know about Tecvayli (teclistamab-cqyv) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

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