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The European Commission has expanded the approval of teclistamab (Tecvayli) monotherapy to cover adults with relapsed/refractory multiple myeloma after just one prior therapy. The decision is backed by phase 3 MajesTEC-9 trial data showing a 71% reduction in disease progression or death vs standard chemotherapy regimens. Nearly two-thirds of patients on teclistamab achieved a complete response or better.
The European Commission (EC) has approved an expanded indication for teclistamab (Tecvayli) monotherapy, now covering adult patients with relapsed/refractory multiple myeloma who have received at least one prior therapy — a significant shift from its original approval, which required at least three prior lines of treatment. This makes teclistamab one of the earliest-line bispecific antibody options available in Europe for myeloma patients.
The approval is anchored in data from the phase 3 MajesTEC-9 trial, which enrolled 593 patients who had received one to three prior lines of therapy. Teclistamab dramatically outperformed standard-of-care regimens (PVd or Kd) across all key efficacy measures, with benefits seen even in high-risk subgroups like those with anti-CD38–refractory or lenalidomide-refractory disease.
By the Numbers:
Why it matters: Myeloma patients typically face shorter remissions with each subsequent treatment line, making effective early intervention critical. Teclistamab's expanded EU approval gives physicians a potent immunotherapy option at first relapse, potentially reshaping the second-line treatment landscape.
