On March 28, 2025, the FDA expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto; Novartis) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and who are considered appropriate to delay taxane-based chemotherapy.1
The FDA based their approval in part on data from PSMAfore (NCT04689828), a randomized, multicenter, open-label trial that enrolled 468 patients with PSMA-positive mCRPC and progression on 1 ARPI. Patients were randomly assigned to receive either lutetium Lu 177 vipivotide tetraxetan (7.4 GBq [200 mCi] every 6 weeks for 6 doses) or a change in ARPI. Patients who progressed on the ARPI arm were allowed to cross over to the experimental therapy.
The median radiographic progression-free survival was 9.3 months (95% confidence interval [CI], 7-not estimable) in the lutetium Lu 177 vipivotide tetraxetan arm and 5.6 months (95% CI, 4-6) in the ARPI arm (hazard ratio [HR] 0.41 [95% CI, 0.29-0.56]; P<.0001). Median OS was 24.5 months (95% CI, 19.5-28.9) and 23.1 months (95% CI, 19.6-25.5) in the respective arms (HR 0.91 [95% CI, 0.72-1.14]; P was not statistically significant). Sixty percent (n=141) of patients who received a change in ARPI crossed over to receive lutetium Lu 177 vipivotide tetraxetan after progression.
FDA officials noted in a release about the expanded indication that patients with previously treated mCRPC should be selected for this regimen using locametz (active ingredient gallium Ga 68 gozetotide) or another approved PSMA positron emission tomography product based on PSMA expression in tumors.
Reference
- FDA. FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication. March 28, 2025. Accessed April 1, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication
