FDA speeds Tecvayli‑Darzalex approval: rare fast‑track nod for myeloma combo

The FDA granted rapid clearance to Johnson & Johnson’s Tecvayli (pirtobrutinib) combined with Darzalex Faspro (daratumumab) for relapsed or refractory multiple myeloma under a priority‑review pilot, citing strong MajesTEC‑3 phase 3 data. The agency also converted Tecvayli’s prior accelerated approval to a traditional approval after confirmatory evidence. Company releases and the FDA noted substantial reductions in progression risk, and the decision marks the third use of the Commissioner’s National Priority Voucher pilot to accelerate an oncology approval.