Johnson & Johnson Announces New Data From Investigational Phase 3 Majestec-3 Study That Show Potential Of TECVAYLI Plus DARZALEX FASPRO As Early As Second Line For Patients With R/R Multiple Myeloma

TECVAYLI® and DARZALEX FASPRO® combination led to a statistically significant progression-free survival and overall survival advantage compared to standard treatment after three years of follow-up

Combination regimen granted Breakthrough Therapy Designation by U.S. FDA

ORLANDO, Fla., Dec. 9, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), the worldwide leader in multiple myeloma, today announced new data from the investigational Phase 3 MajesTEC-3 study that demonstrate the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as early as second line for patients with relapsed/refractory multiple myeloma (RRMM). Results show an 83% reduction in the risk of disease progression or death compared to standard regimens at nearly three-years follow-up (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P<0.0001). Ninety-one percent of patients who were progression-free at six months remained progression-free at three years.