FDA OKs Lutetium Lu 177 Vipivotide Tetraxetan in Metastatic Prostate Cancer

The FDA has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus an androgen receptor pathway inhibitor (ARPI) for patients with prostate-specific membrane antigen (PSMA)–positive androgen pathway modulation-naïve or-sensitive prostate cancer, according to a press release from the FDA.

To be selected for this treatment, active ingredient gallium Ga 68 gozetotide (Locametz) or another PSMA PET product-based on PSMA expression in tumors should be utilized.

The approval was based on results from the phase 3 PSMAddition (NCT04720157) trial. Patients were randomly assigned 1:1 to receive either lutetium Lu 177 vipivotide tetraxetan at 7.4 GBq (200 mCi) every 6 weeks for 6 doses in combination with an ARPI (n = 572) or an ARPI alone (n = 572). Choice of ARPI included abiraterone, apalutamide (Erleada), enzalutamide (Xtandi), darolutamide (Nubeqa), or another ARPI.

Topline data included a median radiographic progression-free survival that was not reached in either arm (HR, 0.72; 95% CI, 0.58-0.90; P = .002). At the time of the current analysis, the overall survival data were still immature.

Toxicity was similar to prior reports of lutetium Lu 177 vipivotide tetraxetan. Warnings and precautions in the prescribing information include risk of radiation exposure, myelosuppression, renal toxicity, embryo-fetal toxicity, and infertility.

Reference

FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. News release. FDA. July 31, 2026. Accessed July 31, 2026. https://tinyurl.com/4xzv5cyw