Full-Life Technologies’ [225Ac]Ac-FL-261 received regulatory clearances in the US and Australia to begin a first-in-human Phase I trial for c-MET-expressing nonsquamous NSCLC. The clearance enables patient dosing plans for evaluating safety and early activity. The candidate represents a targeted approach anchored on c-MET expression, aligning trial strategy with biomarker-defined oncology cohorts. For radiopharmaceutical developers, dual-region clearances can reduce start-up delays and help standardize the early clinical package for subsequent efficacy expansion. The move adds to the expanding competition in targeted alpha therapy, where payload selection and patient selection often determine whether programs transition quickly to dose-expansion cohorts.