FDA clears Pluvicto plus ARPI for PSMA-positive mAPMN/S prostate cancer

The U.S. FDA approved targeted radionuclide therapy LuPSMA-617 (Pluvicto) in combination with an androgen receptor pathway inhibitor (ARPI) on July 31 for PSMA-positive metastatic androgen pathway modulation–naive or–sensitive (mAPMN/S) prostate cancer. The decision was supported by the phase 3 PSMAddition trial, which showed the combination significantly improved radiographic progression-free survival versus ARPI alone. The reported hazard ratio for rPFS was 0.72.