FDA Approves Tecvayli (teclistamab) for Relapsed or Refractory Multiple Myeloma

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.