The FDA granted rapid approval to Johnson & Johnson’s Tecvayli paired with Darzalex Faspro for early relapsed/refractory multiple myeloma using the agency’s Commissioner’s National Priority Voucher (CNPV) pilot, completing review in roughly 55 days. The decision followed MajesTEC‑3 Phase 3 results that showed an 83% reduction in risk of progression or death versus standard regimens and supported conversion of Tecvayli’s accelerated monotherapy approval to a full approval. FDA leadership cited the outstanding trial outcomes as justification for expedited action. J&J said the approval will broaden access to the combination in second‑line settings; payers, clinicians and competitors will be watching how the CNPV pilot shapes future oncology review timelines and regulatory expectations for confirmatory data.