This decision provides a new therapeutic option for patients who have received at least one previous treatment.

Teclistamab is a bispecific antibody administered via subcutaneous injection. It targets B-Cell Maturation Antigen (BCMA) and cluster of differentiation 3 (CD3), prompting an immune response against cancer.

Johnson & Johnson EMEA haematology therapeutic area head Ester in ‘t Groen said: “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.

“By combining the complementary mechanisms of teclistamab, a BCMA×CD3 bispecific antibody, with daratumumab, a well-established standard of care that helps modulate the immune system, we can deliver meaningful long-term outcomes earlier in the treatment journey, where they have the greatest opportunity to influence the disease trajectory and redefine expectations for patients.”

The approval is based on findings from the ongoing Phase III MajesTEC-3 study involving patients with r/r MM who have had one to three previous lines of therapy.

The study compared the safety and efficacy of the new treatment regimen to standard care options, specifically investigating the combination of daratumumab with dexamethasone paired with either pomalidomide or bortezomib.

It included 291 participants receiving the teclistamab and daratumumab combination and 296 on the alternative regimens.

Results from the MajesTEC-3 study indicated substantial improvements in progression-free survival and overall survival for those on the new treatment.

Specifically, the likelihood of disease progression or death was reduced by 83.4% compared to standard treatments, according to the study’s hazard ratio of 0.17. More than 90% of patients who were progression-free at six months remained so at three years, suggesting a durable response.

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