OncologyFDA Approved

177Lu-PSMA-617 (Pluvicto)

Intravenous

Overview

177Lu-PSMA-617 is a radioligand therapeutic consisting of a small peptide-based ligand targeting prostate-specific membrane antigen (PSMA) conjugated to the beta-emitting radioisotope lutetium-177. The peptide component binds selectively to PSMA, a transmembrane protein highly expressed on prostate cancer cells, enabling targeted delivery of cytotoxic radiation to tumor sites while sparing normal tissues.

Mechanism of Action

It is indicated for treatment of metastatic castration-resistant prostate cancer in patients previously treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The targeting moiety is derived from a urea-based peptidomimetic scaffold optimized for PSMA affinity..

Research Summary & Key Findings

177Lu-PSMA-617 received FDA approval in March 2022 based on the VISION trial (NEJM 2021), a randomized phase 3 study demonstrating significant improvements in overall survival (median 15.3 vs 11.3 months) and radiographic progression-free survival compared to standard of care alone. The trial enrolled 831 patients with PSMA-positive metastatic castration-resistant prostate cancer. Treatment-related adverse events included myelosuppression and dry mouth, with the majority of events being grade 1 or 2.

Clinical Status

FDA Approved

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.

Administration Routes

Intravenous

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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.