The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended an indication extension for Johnson & Johnson's Tecvayli (teclistamab), a B-cell maturation antigen (BCMA) × CD3 bispecific T-cell engager. The CHMP is backing use of Tecvayli as monotherapy in adults with relapsed/refractory multiple myeloma who have received at least one prior therapy, substantially earlier than its original later-line setting.
The CHMP opinion is supported by the Phase III MajesTEC-9 study (NCT05572515), which compared teclistamab monotherapy against investigator's choice of pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM who had received one to three prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. The trial's primary endpoint was progression-free survival (PFS). Teclistamab reduced the risk of disease progression or death by 71% (HR 0.29; 95% CI 0.23–0.38) and the risk of death by 40% (HR 0.60; 95% CI 0.43–0.83) versus standard care. Complete response or better was achieved by 65.9% of patients versus 16.8%.
The study population was predominantly refractory to both anti-CD38 therapy and lenalidomide. Grade 3/4 infections occurred more frequently with teclistamab than with standard care, at 41.6% versus 29.0%, although J&J said the incidence of severe infections declined over time.
The recommendation follows European Commission approval in August 2026 of teclistamab in combination with daratumumab for patients with multiple myeloma after at least one prior therapy, giving J&J two teclistamab-based strategies positioned for earlier-line treatment if the monotherapy expansion receives final EC approval.