The FDA’s updated stance on Ebvallo centers on using the existing single-arm Allele trial with an appropriate historical control rather than demanding a new randomized study. The companies said the agency’s position could allow a resubmission plan supported by additional patients and longer follow-up. The shift is especially relevant because Ebvallo targets an ultra-rare population with limited post-transplant options. Failure after anti-CD20 therapy leaves patients with EBV+ PTLD facing very short time-to-progression. Together with the European approval in 2022, the U.S. reconsideration represents the clearest route yet to an FDA decision based primarily on the already-completed study design.