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177Lu-PSMA-617 gained FDA approval in 2023 for patients with PSMA-positive mCRPC after progression on ARi and taxane-based chemotherapy, following the phase III VISION trial demonstrating that the combination of 177Lu-PSMA-617 with best standard-of-care (BSoC) therapy improved median overall survival and radiographic progression-free survival compared to BSoC alone (NCT03511664) 83