Johnson & Johnson reported that Tecvayli produced a substantial survival and disease-control benefit in a Phase 3 study of earlier-line multiple myeloma. In the MajesTEC-9 and related trials J&J cited large reductions in progression or death versus standard regimens, including a 71% lower risk of progression or death in one comparator analysis and a separate 40% reduction in risk of death observed in interim monitoring. The company enrolled 614 relapsed patients who had previously received frontline daratumumab- or lenalidomide-containing regimens and randomized them to Tecvayli or standard triplet/quadruplet therapy. Trial monitors detected an early survival advantage that prompted unblinding and accelerated regulatory engagement; J&J said it will discuss the datasets with the FDA and other agencies and pursue presentations at upcoming medical meetings. Tecvayli’s results underpin J&J’s strategy to move the dual-targeting antibody into earlier lines of therapy and to build a broader myeloma franchise alongside Darzalex and cell therapies. Regulators have signaled interest—FDA granted a “national priority” interaction for related submissions—and the data will shape label expansion and reimbursement discussions for a drug currently approved under accelerated pathways for later-line use.