FDA Approves Radioligand Therapy in PSMA–Positive, Castration-Resistant PC

Data from the PSMAfore trial (NCT04689828) supported the expanded indication for lutetium Lu 177 vipivotide tetraxetan.

The FDA has expanded lutetium Lu 177 vipivotide tetraxetan’s (Pluvicto) indication to include adult patients with prostate-specific membrane antigen (PSMA)–positive, metastatic castration-resistant prostate cancer who received prior androgen receptor pathway inhibitor (ARPI) therapy and are appropriate to delay taxane-based chemotherapy, according to a press release from the FDA.

Supporting data came from the randomized, open-label phase 3 PSMAfore trial (NCT04689828) that enrolled a total of 468 patients who were randomly assigned, in a 1:1 ratio, to receive lutetium Lu 177 vipivotide tetraxetan or a change in ARPI.

The median radiographic progression-free survival (PFS) was 9.3 months (95% CI, 7-not estimable [NE]) with the experimental treatment and 5.6 months (95% CI, 4-6) with ARPI therapy (HR, 0.41; 95% CI, 0.29-0.56; P <.0001). The median overall survival (OS) was 24.5 months (95% CI, 19.5-28.9) vs 23.1 months (95% CI, 19.6-25.5), respectively (HR, 0.91; 95% CI, 0.72-1.14). Also, 60% (n = 114) of patients who were assigned to receive ARPI therapy switched to receive lutetium Lu 177 vipivotide tetraxetan after disease progression.

The safety profile was generally consistent with prior data on lutetium Lu 177 vipivotide tetraxetan, although it was noted that exposure to the treatment may result in risk of renal toxicity, myelosuppression, and radiation exposure.

The recommended dose of lutetium Lu 177 vipivotide tetraxetan is 7.4 GBq (200 mCi) intravenously every 6 weeks for 6 doses. It was also noted that patients should be selected for the agent using the active ingredient gallium Ga 68 gozetotide or another approved PSMA PET product.

Reference

FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication. News release. FDA. March 28, 2025. Accessed March 28, 2025. https://tinyurl.com/y77tmenc