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Lutetium Lu-177 vipivotide tetraxetan

Also called PSMA-617

EvidenceFDA approved

ClassPSMA-targeted radioligand

Lu-177 vipivotide tetraxetan (Pluvicto) is an FDA-approved radiation therapy for PSMA-positive prostate cancer. See how it works and side effects.

Reviewed by: William Maish, MD MBA MPH, Clinical Product Lead
Published: October 5, 2026
Last updated: October 5, 2026

Key takeaway

Lutetium Lu-177 vipivotide tetraxetan (sold as Pluvicto) is a targeted radiation therapy that homes in on a protein found on prostate cancer cells and delivers radiation directly to them. It is used for PSMA-positive metastatic prostate cancer, either after other treatments have stopped working or earlier alongside hormone therapy. It has been FDA-approved in the U.S. since 2022 and is given as a series of intravenous infusions.

At a glance

What it is	A PSMA-targeted radioligand therapy labeled with lutetium-177
Approved for	PSMA-positive metastatic prostate cancer, both castration-resistant disease and, with a hormone-blocking drug, disease that still responds to hormone therapy
Key fact	In the VISION trial it improved both progression-free and overall survival when added to standard care
Route	Intravenous infusion, up to six cycles six weeks apart
Evidence strength	FDA approved

What is lutetium Lu-177 vipivotide tetraxetan?

Lutetium Lu-177 vipivotide tetraxetan, sold under the brand Pluvicto, is a radioligand therapy that links a molecule targeting prostate-specific membrane antigen (PSMA) to the radioactive isotope lutetium-177. It is used for advanced prostate cancer whose cells carry PSMA. It is also known in the literature as 177Lu-PSMA-617, and it was approved in the United States in 2022.

How does lutetium Lu-177 vipivotide tetraxetan work?

Prostate cancer cells typically display large amounts of PSMA, a protein on their surface. The targeting part of this drug binds PSMA, and the attached lutetium-177 emits beta-particle radiation over a short range. Because the drug accumulates on PSMA-bearing cells, it delivers a concentrated dose of radiation to the cancer and its immediate surroundings while limiting exposure to more distant healthy tissue, causing lethal DNA damage in the targeted cells.

Patients are selected using a PSMA PET scan to confirm the target is present before treatment. In the VISION trial, adding this radioligand therapy to standard care improved both imaging-based progression-free survival¹ and overall survival compared with standard care alone, in men whose disease had progressed after hormonal and chemotherapy treatment.

Is it FDA-approved?

Yes. Lutetium Lu-177 vipivotide tetraxetan (Pluvicto) is FDA-approved, and its indication has widened in steps:

Year	FDA action
2022	Approved² for PSMA-positive metastatic castration-resistant prostate cancer, initially after hormonal and taxane chemotherapy
2025	Indication broadened to patients who have not yet had chemotherapy
2026	Added³ use alongside a hormone-blocking drug for metastatic prostate cancer that still responds to hormone therapy

It is given as an intravenous infusion, up to six cycles about six weeks apart.

What is lutetium Lu-177 vipivotide tetraxetan prescribed for?

It is prescribed for PSMA-positive metastatic prostate cancer, confirmed by a PSMA PET scan. That includes castration-resistant cancer that has progressed on hormone-blocking therapy and, in combination with a hormone-blocking drug, cancer that still responds to hormone therapy. It is administered in specialized centers equipped to handle radiopharmaceuticals.

What are the side effects?

According to the prescribing information², common side effects include:

Fatigue
Dry mouth
Nausea and decreased appetite
Anemia and constipation

More serious considerations include:

Bone-marrow suppression
Kidney toxicity
Radiation exposure and precautions to protect others
Effects on fertility

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Sources: FDA prescribing information for Pluvicto; the VISION trial (Sartor et al., New England Journal of Medicine, 2021, DOI: 10.1056/NEJMoa2107322¹), indexed on PubMed. This document is educational and does not constitute medical advice.