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Prescribing information (external link)
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Pluvicto®▼ (lutetium [177Lu] vipivotide tetraxetan)
Pluvicto is indicated for the treatment of adult patients with:1
Prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have progressed on or after treatment with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy
PSMA-positive mCRPC who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes
Pluvicto Summary of Product Characteristics (SmPC) can be found here
Pluvicto is now licensed for eligible mCRPC patients without prior chemotherapy1
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Here, you can access relevant information on Pluvicto and a range of engaging resources to solidify your knowledge. Click the links below to explore Pluvicto's mechanism of action, dosing and administration and key efficacy and safety profile data from the PSMAfore study and VISION trial.1–3
The safety profile of Pluvicto was evaluated in two trials, PSMAfore and VISION. In PSMAfore, the most common (≥20%) adverse drug reactions (ADRs) occurring in patients who received Pluvicto include: dry mouth (60.8%), fatigue (52.9%), nausea (31.7%), anaemia (27.3%), constipation (22.0%), and decreased appetite (21.6%). The most common grade 3 to 4 ADRs (≥5%) occurring in patients who received Pluvicto include: anaemia (6.2%).1
In VISION, the most common (≥20%) ADRs occurring at a higher incidence in patients who received Pluvicto + BSoC compared to BSoC alone include: fatigue (48.0%), dry mouth (39.3%), nausea (35.7%), anaemia (31.9%), decreased appetite (21.4%) and constipation (20.2%). The most common grade 3 to 4 ADRs (≥5%) occurring at a higher incidence in patients who received Pluvicto + BSoC compared to BSoC alone include: anaemia (12.9%), thrombocytopenia (7.9%), lymphopenia (7.8%) and fatigue (6.6%).1
The data from the PSMAfore and VISION trials cannot be extrapolated to any other lutetium PSMA therapy.
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177Lu, lutetium-177; ADR, adverse drug reaction; AR, androgen receptor; ARPI, androgen receptor pathway inhibitor; BSoC, best standard of care; mCRPC, metastatic castration-resistant prostate cancer; PSMA, prostate-specific membrane antigen; SmPC, summary of product characteristics.
References
Pluvicto®▼ (lutetium [177Lu] vipivotide tetraxetan) Summary of Product Characteristics.
Sartor O, et al. N Engl J Med 2021;385(12):1091–1103.
Morris MJ, et al. Lancet 2024;404:1227–1239.
UK | February 2026 | FA-11470213-3
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.
