The FDA granted rapid approval to Johnson & Johnson’s Tecvayli in combination with Darzalex Faspro for previously treated multiple myeloma under the agency’s Commissioner’s National Priority Voucher pilot, marking a notably expedited review. The decision converted Tecvayli’s prior accelerated approval into a full approval after confirmatory phase‑3 data. Results from the MajesTEC‑3 phase‑3 trial showed a large reduction in progression or death versus standard regimens, driving the agency’s use of the CNPV pathway. FDA leadership framed the move as an urgent patient‑centric action driven by unusually strong clinical evidence; the rapid clearance will affect treatment standards and trial planning in second‑line myeloma.