FDA Approves Pluvicto With ARPI for Prostate Cancer

The FDA approved an additional indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis), expanding the drug’s use to combination therapy with an androgen receptor pathway inhibitor (ARPI). The new indication covers adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer. The FDA stated that patients should be selected for Pluvicto using gallium Ga 68 gozetotide (Locametz) or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors.

Efficacy was evaluated in PSMAddition, a randomized, multicenter, open-label trial involving 1,144 patients with PSMA-positive mAPMN/S prostate cancer. Patients were assigned 1:1 to receive Pluvicto at 7.4GBq (200mCi) intravenously every 6 weeks for 6 doses plus an ARPI or an ARPI alone, with 572 patients in each group. ARPIs selected by investigators included abiraterone, apalutamide, enzalutamide, darolutamide, or another ARPI.

The major efficacy outcome was radiographic progression-free survival (rPFS), as determined by blinded independent central review according to Prostate Cancer Working Group 3-modified RECIST version 1.1 criteria. Pluvicto plus an ARPI produced a statistically significant improvement in rPFS compared with an ARPI alone. Median rPFS was not reached in either group. Overall survival data were immature at the analysis.

The FDA reported that adverse reactions were consistent with prior experience with Pluvicto. The prescribing information includes warnings and precautions concerning radiation exposure, myelosuppression, renal toxicity, embryo-fetal toxicity, and infertility.

Source: US Food and Drug Administration. FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. FDA approval notification. US Food and Drug Administration; July 31, 2026. Accessed August 1, 2026.