The European Commission has approved a new combination use of Johnson & Johnson’s Tecvayli (teclistamab) for multiple myeloma — backed by trial data showing a striking reduction in the risk of the cancer worsening.
The approval covers teclistamab combined with daratumumab for adults with relapsed or refractory multiple myeloma who have had at least one prior treatment. Teclistamab is a bispecific antibody that grabs both BCMA (a protein on myeloma cells) and CD3 (on T cells), bringing the immune system into direct contact with the cancer.
The data
Approval rests on the Phase 3 MajesTEC-3 trial: 291 patients received teclistamab plus daratumumab versus 296 on standard care (daratumumab with dexamethasone plus pomalidomide or bortezomib). The combination cut the risk of disease progression or death by 83.4% (hazard ratio 0.17), and over 90% of patients who were progression-free at six months remained so at three years.
Why it matters
Multiple myeloma remains incurable, and patients typically cycle through multiple therapies as the disease returns. “This new indication…brings forward a new standard of care for patients in Europe,” said J&J’s EMEA haematology lead, Ester in ’t Groen. Bringing a potent immunotherapy combination to an earlier line of treatment could meaningfully extend the time patients spend in remission.