The U.S. Food and Drug Administration has approved a new drug called Tecvayli (teclistamab) for adults with multiple myeloma, a type of blood cancer. This medicine is for patients whose cancer has returned or stopped responding to previous treatments. Tecvayli works by helping the immune system attack cancer cells. It can be used alone for patients who have already tried at least four other types of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. It can also be used in combination with two other drugs (daratumumab and hyaluronidase) for patients who have had at least one prior line of therapy that included a proteasome inhibitor and an immunomodulatory agent. Tecvayli is given as an injection under the skin. To reduce the risk of a serious side effect called cytokine release syndrome, the dose is increased gradually over several days. Patients must stay in the hospital for 48 hours after the first two step-up doses. This approval gives patients with advanced multiple myeloma a new treatment option. However, like all medicines, Tecvayli may not be right for everyone. If you or a loved one has multiple myeloma, talk to your doctor about whether Tecvayli could be an option for your specific situation.
FDA approved Tecvayli (teclistamab) for Relapsed or Refractory Multiple MyelomaFDA approved new drug Tecvayli for advanced multiple myeloma.
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The FDA has approved Tecvayli (teclistamab), a bispecific BCMA-directed CD3 T-cell engager, for the treatment of adult patients with relapsed or refractory multiple myeloma. The approval covers two indications: in combination with daratumumab and hyaluronidase-fihj for patients who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, and as monotherapy for patients who have received at least four prior lines including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Tecvayli is administered subcutaneously with a step-up dosing schedule to mitigate cytokine release syndrome. Patients must be hospitalized for 48 hours after the first two step-up doses. This approval provides a new option for heavily pretreated patients with multiple myeloma.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Tecvayli is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It binds to BCMA on multiple myeloma cells and CD3 on T-cells, activating T-cells to kill myeloma cells.
Tecvayli is indicated for adult patients with relapsed or refractory multiple myeloma: in combination with daratumumab and hyaluronidase-fihj after at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent; or as monotherapy after at least four prior lines including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Tecvayli is for subcutaneous injection only. A step-up dosing schedule is required to reduce CRS risk: step-up dose 1 (0.06 mg/kg) on day 1, step-up dose 2 (0.3 mg/kg) 2-4 days later, and first treatment dose (1.5 mg/kg) 2-4 days after step-up dose 2. Patients must be hospitalized for 48 hours after step-up doses 1 and 2. For combination therapy, Tecvayli is given with daratumumab and hyaluronidase-fihj on a weekly, biweekly, or every-four-weeks schedule depending on treatment week. For monotherapy, after step-up dosing, Tecvayli is given weekly (1.5 mg/kg) for weeks 2-8, then every two weeks (3 mg/kg) for weeks 9-24, then every four weeks (3 mg/kg) from week 25 onward. Pretreatment medications are recommended. Dosage adjustments for body weight are required.
Trial data not available in label.
Warnings include cytokine release syndrome (CRS) and neurologic toxicity including ICANS. Patients should be hospitalized for 48 hours after step-up doses 1 and 2. No contraindications are listed in the label.
Tecvayli is a treatment option for relapsed or refractory multiple myeloma after prior therapies, including as monotherapy for heavily pretreated patients who have received a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody.
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