Did FDA approve Pluvicto earlier for PSMA-positive metastatic prostate cancer?

Yes. On July 31, 2026, FDA approved Novartis’ Pluvicto with androgen receptor pathway inhibitor therapy for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, based on the PSMAddition trial showing improved radiographic progression-free survival. Use requires PSMA PET-based patient selection such as Locametz.