The FDA granted speedy approval to Johnson & Johnson’s Tecvayli (teclistamab) combined with Darzalex Faspro (daratumumab‑fatum) for previously treated multiple myeloma under the Commissioner’s National Priority Voucher (CNPV) pilot, after MajesTEC‑3 data showed a large reduction in progression or death. The agency also converted Tecvayli’s accelerated approval to full approval based on confirmatory results. FDA Commissioner Marty Makary framed the move as an urgent, patient‑focused action. The decision illustrates the agency’s willingness to compress review timelines for high‑impact oncology regimens and may encourage sponsors to pursue the CNPV pathway for transformative trial readouts.