The FDA granted expedited approval to Johnson & Johnson’s Tecvayli (teclistamab) combined with Darzalex Faspro (daratumumab) for previously treated multiple myeloma under the Commissioner’s National Priority Voucher pilot, moving the review in weeks rather than months. The decision also converted Tecvayli’s accelerated approval to a full approval based on confirmatory MajesTEC‑3 trial results. MajesTEC‑3 showed a substantial 83% reduction in risk of progression or death for the Tecvayli‑Darzalex pairing versus standard regimens, with durable progression‑free survival and overall survival improvements. FDA statements framed the result as a significant advance in second‑line myeloma care and justified the rapid review. The action underscores the agency’s willingness to deploy priority mechanisms for high‑impact oncology results, which may accelerate adoption and reimbursement discussions but also puts pressure on manufacturing, supply and post‑marketing safety surveillance.