The European Commission (EC) has approved an expanded indication for Johnson & Johnson’s Tecvayli (teclistamab) in combination with daratumumab for adults with relapsed or refractory multiple myeloma (r/r MM) who have received at least one prior line of therapy.

The decision introduces the teclistamab-daratumumab combination as an earlier treatment option for eligible patients with relapsed or refractory disease. 

Teclistamab is a subcutaneous bispecific antibody that targets B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells, helping activate the immune system against cancer cells.

The approval is supported by results from the ongoing Phase III MajesTEC-3 study, which evaluated patients with r/r MM who had received one to three previous lines of therapy. The trial included 291 patients treated with teclistamab plus daratumumab and 296 patients receiving standard regimens comprising daratumumab and dexamethasone combined with either pomalidomide or bortezomib.

The combination demonstrated significant improvements in both progression-free survival (PFS) and overall survival (OS). According to the study, the risk of disease progression or death was reduced by 83.4%, with a hazard ratio of 0.17 versus standard treatment.

The durability of response was also highlighted, with more than 90% of patients who remained progression-free at six months continuing to be progression-free at three years.

“This new indication for teclistamab plus daratumumab brings forward a new standard of care for patients in Europe living with relapsed or refractory multiple myeloma,” said Ester in ‘t Groen, EMEA Haematology Therapeutic Area Head, Johnson & Johnson.

She said combining the complementary mechanisms of teclistamab, a BCMA×CD3 bispecific antibody, and daratumumab could deliver meaningful long-term outcomes earlier in the treatment journey.

The European approval expands the potential role of Tecvayli beyond later-line treatment, positioning the BCMA-targeted therapy earlier in the treatment pathway for patients with relapsed or refractory multiple myeloma.