Johnson & Johnson reported positive Phase 3 trial results showing Tecvayli reduced the risk of progression or death by 71% in patients with relapsed multiple myeloma compared with standard regimens, and secondary analyses reported survival benefits. The MajesTEC‑9 readout enrolled patients after frontline relapse and the company plans regulatory discussions to extend Tecvayli’s label into earlier lines of therapy. J&J emphasized the trial’s impact on its broader myeloma franchise, which includes multiple antibody and cellular assets. FDA engagement has been proactive: the agency assigned a national priority review flag to a related Tecvayli filing, reflecting regulatory interest in accelerated review pathways for transformative oncology agents.