Lutetium Lu-177 vipivotide tetraxetan
PSMA-targeted radioligand
Also Pluvicto, Lu-177 PSMA-617, 177Lu-PSMA-617, PSMA-617, Lutetium-177 PSMA, Lu-PSMA
- Evidence
- AStrong human evidence
- FDA status
- FDA approvedas of 2026-10-26
- Route
- Intravenous
- Studies cited
- 1 human0 animal or cell
A radioactive drug that finds and attacks prostate cancer cells. In 831 men it added about four months of life, and more trials back its use earlier.
Sold for
Pluvicto is talked about as the proof that radioligand therapy works in a common cancer, and as a multibillion-dollar product that keeps moving earlier in prostate cancer treatment.
Studies say
An 831-patient randomized trial showed a four-month survival gain, and further randomized trials supported earlier use, which is an A for its approved indications.
Why grade A. 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
FDA. Approved. Lutetium Lu-177 vipivotide tetraxetan (Pluvicto, Novartis) was approved in March 2022 for PSMA-positive metastatic castration-resistant prostate cancer after androgen receptor pathway inhibition and taxane chemotherapy, extended in March 2025 to patients who have not had chemotherapy, and extended again in mid-2026 to PSMA-positive metastatic hormone-sensitive prostate cancer in combination with an androgen receptor pathway inhibitor and androgen deprivation therapy. 23
Written from 3 cited sources. Fact-checked 2026-10-27: 19 claims checked, 4 corrected. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Treating advanced prostate cancer.
- Can a US doctor prescribe it?
- Yes, FDA approved for advanced prostate cancer that has spread and carries a marker called PSMA.
- Properly tested in people?
- Yes, in large controlled trials: an 831-man trial and more.
Evidence checklist
- Randomised controlled trial VISION, open-label, versus standard careyes
- Human study over 100 people VISION 831 menyes
- More than one research group Sponsor-run trials; independent work not citedno information
- Clinical outcomes, not surrogate markers Overall survival 15.3 vs 11.3 monthsyes
- Human safety data beyond case reports Trial and label safety datayes
Drawn from the cited studies below. A dash means the sources give no information.
What it is
Lutetium Lu-177 vipivotide tetraxetan is a radioligand. It has two parts. One is a small molecule, vipivotide tetraxetan (also called PSMA-617). It binds prostate-specific membrane antigen. A chelator links it to lutetium-177. This is a radioactive metal that emits beta particles. PSMA is a protein found on most prostate cancer cells. It is much rarer on normal tissue. The ligand is a peptidomimetic. That is a peptide-like molecule with a changed backbone. 2
Novartis sells it as Pluvicto. Patients get it as an intravenous infusion in a nuclear medicine unit. First they need a PSMA PET scan. It must show that their tumors take up a PSMA tracer. The approved use has widened in three steps since 2022. It began with heavily pretreated castration-resistant disease. Next came castration-resistant disease before chemotherapy. Now it also covers hormone-sensitive metastatic disease. There it is given alongside hormone therapy. 23
How it works
The ligand binds PSMA on the cancer cell surface. The cell takes it in, carrying lutetium-177 inside. The beta particles deposit their energy within a couple of millimeters. They break DNA strands in the target cell and its neighbors. PSMA is also found in salivary glands, kidneys and small intestine. So those organs get some dose. This explains the dry mouth. It also explains the kidney monitoring. 2
What human research shows
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
PSMAddition tested hormone-sensitive metastatic disease. Adding the radioligand to standard hormone therapy cut the risk of progression or death by about 28 percent. This supported the 2026 expansion. Overall survival data are not yet mature. 3
| Study | Model | Finding |
|---|---|---|
| VISION (Sartor 2021) | Humans, n=831 with PSMA-positive mCRPC after ARPI and taxane, randomized open-label phase 3 | Median overall survival 15.3 versus 11.3 months and radiographic PFS 8.7 versus 3.4 months with the radioligand added to standard care. 1 |
| Pluvicto prescribing information (2026) | FDA label including PSMAfore and PSMAddition randomized trials | PSMAfore: radiographic PFS 9.3 versus 5.6 months (HR 0.41) with no significant overall survival difference after 60% crossover. PSMAddition: 28% lower risk of progression or death (HR 0.72), survival data immature. 3 |
| Pluvicto prescribing information (Novartis) | FDA label | Myelosuppression, kidney toxicity, dry mouth, and radiation precautions as the main safety issues. 2 |
Safety
In VISION, the most common adverse events were fatigue, dry mouth, nausea, anemia and loss of appetite. Grade 3 or higher events occurred in 53 percent of the radioligand arm. In controls it was 38 percent. Low blood counts drove the gap. The label warns of myelosuppression. It warns of kidney toxicity. It warns of radiation exposure to others. It advises contraception. The drug can harm sperm and a fetus. 12
Dry mouth is more frequent than with lutetium dotatate. Salivary glands carry PSMA. Secondary cancers from marrow irradiation are a theoretical concern. Follow-up so far is too short to size that risk. 2
Questions for your clinician
- Does my scan show PSMA-positive disease?
- What are the effects on blood counts, kidneys and dry mouth?
- What radiation precautions apply to my family?
Questions people ask
Who is eligible for Pluvicto?
Men with metastatic prostate cancer whose tumors show PSMA uptake on a PET scan. Since 2026 that includes hormone-sensitive disease given with hormone therapy. It also includes castration-resistant disease. This can be before or after chemotherapy. 23
How much does it extend life?
In VISION, median survival was 15.3 months versus 11.3 months in heavily pretreated men. In the earlier-stage trials, the benefit shown is delayed progression. PSMAfore found no significant survival difference. Most control patients later switched to Pluvicto. PSMAddition survival results are not yet mature. 13
Citations
- Sartor 2021, NEJM: Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer (VISION) doi.org
- Novartis: Pluvicto US prescribing information novartis.com
- FDA 2026: Pluvicto prescribing information, expanded indication accessdata.fda.gov