Novartis' Pluvicto Gets US FDA Nod for Metastatic Prostate Cancer Treatment

01:45 AM EDT, 08/02/2026 (MT Newswires) -- Novartis (NOVN.SW) secured the US Food and Drug Administration's approval for the treatment of patients with prostate-specific membrane antigen-positive metastatic hormone-sensitive prostate cancer using Pluvicto plus an androgen receptor pathway inhibitor. The approval was based on the phase III PSMAddition trial, updated results of which showed that Pluvicto, in combination with standard of care, lowered the risk of progression or death by 33%, compared with just standard of care, the innovative medicines company said July 31. The authorization makes Pluvicto eligible for use across all stages of PSMA-positive metastatic prostate cancer.