The FDA issued a rapid approval for Johnson & Johnson’s Tecvayli plus Darzalex regimen in relapsed or refractory multiple myeloma under the Commissioner’s National Priority Voucher (CNPV) pilot, completing review in roughly two months. The agency also converted Tecvayli’s accelerated monotherapy approval to full approval based on confirmatory MajesTEC‑3 data showing a large progression‑free survival benefit. FDA Commissioner Marty Makary cited the trial’s unusually strong outcomes as justification for expedited action. The decision highlights the agency’s willingness to compress review timelines for high‑impact oncology results and sets precedence for the nascent CNPV pilot.