The FDA approved Johnson & Johnson’s Tecvayli plus Darzalex Faspro combination for previously treated multiple myeloma and converted Tecvayli’s accelerated monotherapy approval to full approval after the MajesTEC‑3 phase 3 confirmatory data showed an 83% reduction in progression or death. The agency used its Commissioner’s National Priority Voucher pilot to expedite review, issuing clearance about 55 days after submission. Regulators cited the magnitude of MajesTEC‑3’s benefit—high progression‑free and overall survival gains—as justification for rapid action. J&J moved quickly through supplemental filings and Real‑Time Oncology Review channels; the approval reshapes the second‑line myeloma landscape and may pressure competitors to accelerate combination strategies or new comparator trials.