Lutetium Lu-177 vipivotide tetraxetan: evidence, FDA status and research

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: a small molecule (vipivotide tetraxetan, also known as PSMA-617) that binds prostate-specific membrane antigen, linked through a chelator to the beta-emitting radioactive metal lutetium-177. PSMA is a protein present on most prostate cancer cells and at much lower levels on normal tissue. The ligand is a peptidomimetic, a peptide-like molecule with a modified backbone. ²

Novartis sells it as Pluvicto, given as an intravenous infusion in a nuclear medicine setting. Patients must first have a PSMA PET scan showing their tumors take up a PSMA tracer. The indication has widened in three steps since 2022, from heavily pretreated castration-resistant disease, to castration-resistant disease before chemotherapy, to hormone-sensitive metastatic disease given alongside hormone therapy. ²³

How it works

The ligand binds PSMA on the cancer cell surface and is internalized, carrying lutetium-177 inside. The beta particles deposit their energy within a couple of millimeters, breaking DNA strands in the targeted cell and its neighbors. Because PSMA is also expressed in salivary glands, kidneys, and small intestine, those organs receive some dose, which explains the dry mouth and the kidney monitoring. ²

What human research shows

VISION randomized 831 men with PSMA-positive metastatic castration-resistant prostate cancer who had progressed after at least one androgen receptor pathway inhibitor and one or two taxane regimens to radioligand plus standard care or standard care alone. Median overall survival was 15.3 months versus 11.3 months (hazard ratio 0.62), and 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, in men who had progressed on an androgen receptor pathway inhibitor but not yet had chemotherapy, extended median radiographic progression-free survival to 9.3 months from 5.6 months with a switch to another hormone drug (hazard ratio 0.41), supporting the 2025 expansion. Overall survival did not differ significantly (24.5 versus 23.1 months), and 60% of the control group crossed over to the radioligand after progression. PSMAddition, in hormone-sensitive metastatic disease, cut the risk of progression or death by about 28 percent when the radioligand was added to standard hormone therapy, supporting the 2026 expansion; overall survival data there 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 versus 38 percent of controls, driven by low blood counts. The label warns of myelosuppression, kidney toxicity, and radiation exposure to others, and advises contraception because of the risk to sperm and a fetus. ¹²

Dry mouth is more frequent than with lutetium dotatate because salivary glands express PSMA. Secondary cancers from marrow irradiation are a theoretical concern that the follow-up so far is too short to quantify. 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, as well as castration-resistant disease 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 in delaying progression: PSMAfore found no significant survival difference, with most control patients later switching to Pluvicto, and PSMAddition survival results are not yet mature. ¹³

Is it the same as Lutathera?

Both use lutetium-177, but Lutathera's carrier is a somatostatin analog for neuroendocrine tumors while Pluvicto's carrier targets PSMA on prostate cancer cells. ¹²

Which adverse effects occur most often?

Fatigue, dry mouth, nausea, and low blood counts. Kidney function and blood counts are checked before each dose, and patients are told how to limit radiation exposure to others for a few days. ¹²

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