Peptide Graded

Lutetium Lu-177 vipivotide tetraxetan

Does Lutetium Lu-177 vipivotide tetraxetan work?

Yes, in large controlled trials: an 831-man trial and more.

AStrong human evidenceFDA approvedas of 2026-10-26

The original approval rests on VISION, a randomized open-label phase 3 trial in 831 men that showed longer overall survival and progression-free survival over standard care alone. Later expansions rest on PSMAfore and PSMAddition, randomized trials summarized in the label. The open question is overall survival in the earlier settings: PSMAfore showed no significant survival difference, with most control patients crossing over to the radioligand, and PSMAddition survival data are immature. 13

VISION randomized 831 men. All had PSMA-positive metastatic castration-resistant prostate cancer. Their disease had grown after treatment. They had had at least one androgen receptor pathway inhibitor. They had also had one or two taxane regimens. Half got the radioligand plus standard care. Half got standard care alone. Median overall survival was 15.3 months versus 11.3 months (hazard ratio 0.62). Median radiographic progression-free survival was 8.7 versus 3.4 months. Half the treated patients had a PSA fall of at least 50 percent. 1

PSMAfore enrolled men whose disease had grown on an androgen receptor pathway inhibitor. They had not yet had chemotherapy. With the radioligand, median radiographic progression-free survival was 9.3 months. With a switch to another hormone drug, it was 5.6 months (hazard ratio 0.41). This supported the 2025 expansion. Overall survival did not differ significantly (24.5 versus 23.1 months). 60% of the control group crossed over to the radioligand after progression. 3

Evidence checklist

  • Randomised controlled trial VISION, open-label, versus standard care
  • Human study over 100 people VISION 831 men
  • More than one research group Sponsor-run trials; independent work not cited
  • Clinical outcomes, not surrogate markers Overall survival 15.3 vs 11.3 months
  • Human safety data beyond case reports Trial and label safety data

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Citations

  1. Sartor 2021, NEJM: Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer (VISION) doi.org
  2. Novartis: Pluvicto US prescribing information novartis.com
  3. FDA 2026: Pluvicto prescribing information, expanded indication accessdata.fda.gov

Reference information only, not medical advice. Drawn from the Lutetium Lu-177 vipivotide tetraxetan article, fact-checked against the cited sources. No dosing anywhere on this site.