Johnson & Johnson announced on March 5, 2026 that the U.S. Food and Drug Administration (FDA) approved 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. TECVAYLI® (teclistamab-cqyv) is a first-in-class, bispecific T-cell engager antibody that binds to CD3 and B-cell maturation antigen (BCMA) that was approved by FDA in 2022. DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) is a CD38-directed antibody co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) that was approved by FDA in May 2020. According to J&J, the approval of TECVAYLI® plus DARZALEX FASPRO® offers a potential new standard of care (SOC) as early as second line and brings a novel treatment approach for the 40% of patients with multiple myeloma who experience disease relapse.
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