The FDA granted rapid approval to Johnson & Johnson’s Tecvayli plus Darzalex regimen for previously treated multiple myeloma under the Commissioner’s National Priority Voucher pilot, completing review in 55 days. The approval followed MajesTEC‑3 phase 3 results that showed an 83% reduction in risk of progression or death compared with standard regimens. The agency also converted Tecvayli’s accelerated approval to a full approval based on the confirmatory data. FDA Commissioner Marty Makary emphasized the trial’s unprecedented outcomes and the agency’s obligation to act swiftly when robust evidence emerges. The decision illustrates the FDA’s willingness to use expedited review pathways for oncology regimens with large, confirmatory effect sizes. Competitors and clinicians will reassess treatment sequencing in second‑line myeloma as commercial uptake accelerates.