The FDA granted full approval to Johnson & Johnson’s Tecvayli as a monotherapy and cleared the Tecvayli plus Darzalex Faspro combination for previously treated relapsed or refractory multiple myeloma under the Commissioner’s National Priority Voucher (CNPV) pilot. The decision followed J&J’s phase 3 MajesTEC‑3 results showing a marked reduction in progression or death versus standard regimens. The agency upgraded Tecvayli’s accelerated approval after MajesTEC‑3 provided confirmatory evidence; the Tecvayli‑Darzalex pairing received expedited review under the CNPV pilot aimed at drugs meeting U.S. national priorities. FDA statements cited very large effect sizes and durable progression‑free survival, prompting unusually rapid action under accelerated frameworks. Clinically, the approval expands second‑line options for myeloma and converts an accelerated pathway into traditional licensure, affecting commercial planning and competitor positioning in bispecific and antibody combination space.