Tecvayli, First Bispecific BCMA-Directed CD3 T-Cell Engager, Received FDA Approval for Relapsed or Refractory Multiple Myeloma

December 2022, Vol 13, No 6


On October 25, 2022, the FDA accelerated the approval of teclistamab-cqyv (Tecvayli; Janssen Biotech), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who received ≥4 previous lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. The FDA granted teclistamab breakthrough therapy and orphan drug designations.

The FDA approved teclistamab based on the results of the MajesTEC-1 clinical trial, a single-arm, multicohort, open-label, multicenter study. The efficacy was evaluated in 110 patients who had received ≥3 previous therapies, including a PI, an IMiD, and an anti-CD38 monoclonal antibody, and had not received previous BCMA-targeted therapy.

The overall response rate, the study’s main efficacy measure, with teclistamab was 61.8% (95% confidence interval [CI], 52.1-70.9). With a median follow-up of 7.4 months, the estimated duration of response was 90.6% (95% CI, 80.3%-95.7%) at 6 months and 66.5% (95% CI, 38.8%-83.9%) at 9 months.

The most common (≥20%) adverse events in the 165 patients in the safety population were pyrexia, cytokine release syndrome (CRS), musculoskeletal pain, injection-site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common (≥20%) grade 3 or 4 laboratory events were decreased levels of lymphocytes, neutrophils, white blood cells, hemoglobin, and platelets.

The prescribing information for teclistamab includes a boxed warning for CRS and neurologic adverse events, including immune effector cell–associated neurotoxicity syndrome (ICANS). In the study, 72% of patients had CRS, including 0.6% grade 3; 57% had neurologic events, including 2.4% grade 3 or 4; and 6% had ICANS. Therefore, teclistamab was approved with a REMS (Risk Evaluation and Mitigation Strategy) program.

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