Healthcare products company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for its TECVAYLI (teclistamab-cqyv) plus DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.

TECVAYLI and DARZALEX FASPRO work synergistically to prime and activate the immune system to eradicate myeloma cells that express the BCMA protein. According to J&J, TECVAYLI in combination with DARZALEX FASPRO demonstrated statistically significant improvements in progression-free survival in patients with RRMM compared to standard treatment after a median follow-up of three years.

This approval offers a potential new standard of care as early as second line and brings a novel treatment approach for the 40% of patients with multiple myeloma who experience disease relapse.

The decision was based on data from the Phase 3 MajesTEC-3 study, an ongoing, Phase 3 randomised study assessing the safety and efficacy of teclistamab plus daratumumab compared to investigator's choice of daratumumab and dexamethasone with either pomalidomide or bortezomib in patients with RRMM who have received at least one prior line of therapy.