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Oncology · FDA Approved

177Lu-PSMA-617 (Pluvicto)

FDA-approved

How to ask your doctor
Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

177Lu-PSMA-617 (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapy that pairs a small urea-based peptidomimetic ligand for prostate-specific membrane antigen (PSMA) with the beta-emitting radioisotope lutetium-177. PSMA is highly expressed in metastatic castration-resistant prostate cancer, and the ligand delivers beta radiation to PSMA-expressing cells and their surrounding microenvironment (PMID 34161051).

It was first approved for PSMA-positive metastatic castration-resistant prostate cancer previously treated with an androgen receptor pathway inhibitor and taxane chemotherapy (PMID 36469000). The targeting moiety is derived from a urea-based scaffold optimized for PSMA affinity.

02 · Research summary & key findings

The FDA approved 177Lu-PSMA-617 on March 23, 2022, based on the VISION trial (PMID 36469000). VISION (NEJM 2021) randomized 831 patients and showed longer overall survival (median 15.3 vs 11.3 months) and imaging-based progression-free survival (median 8.7 vs 3.4 months) when added to standard care; grade 3 or higher adverse events were more frequent (52.7% vs 38.0%) (PMID 34161051). The most common adverse reactions were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation (PMID 36469000). In the phase 3 PSMAfore trial in taxane-naive patients, it prolonged radiographic progression-free survival compared with a change of androgen receptor pathway inhibitor (PMID 39293462).

03 · Regulatory status

177Lu-PSMA-617 (Pluvicto) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

177Lu-PSMA-617 (Pluvicto) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.

04 · Administration routes

  • Intravenous

References

  1. [1]Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer N Engl J Med, 2021. PMID 34161051
  2. [2]FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer Clin Cancer Res, 2023. PMID 36469000
  3. [3](177)Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial Lancet, 2024. PMID 39293462

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.