Prescribing information

This page/content is for Great Britain healthcare professionals only.

Pluvicto® is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.2

 

Pluvicto®

The first and only licensed PSMA-targeted radioligand therapy (RLT) that, when used alongside BSoC, significantly extends survival and maintains quality of life for longer, vs BSoC alone, in eligible PSMA-positive mCRPC patients.1,2

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Pluvicto mechanism of action

Pluvicto targets PSMA-positive cells, including prostate cancer cells.2

Show more about Pluvicto mechanism of action

 

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Safety profile and efficacy

The efficacy and safety profile of Pluvicto + BSoC were assessed in the VISION trial.1

Show more on safety profile and efficacy

 

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Dosing and administration

Pluvicto is a ready-to-use solution administered intravenously.2

Read more about dosing and administration

 

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The most common ADRs (≥20%) occurring at a higher incidence in patients who received Pluvicto + BSoC compared to BSoC alone include: fatigue, dry mouth, nausea, anaemia, decreased appetite and constipation.

 

*In VISION, a randomised, open-label, multicentre, phase 3 clinical trial (n=831), Pluvicto prolonged overall survival, imaging-based progression-free survival, and maintained quality of life for longer when used alongside best standard of care compared to best standard of care alone.

Alternate primary endpoints: Overall survival was improved by 4 months vs BSoC (HR 0.62, 95% CI, 0.52–0.74; p<0.001), radiographic progression-free survival was improved by 5.3 months vs BSoC (HR 0.40, 99.2% CI, 0.29–0.57; p<0.001).

Secondary endpoint: Quality of life measured as FACT-P total score was maintained by 3.5 months more vs BSoC (HR 0.54, 95% CI, 0.45–0.66; nominal p-value with non-inferential analysis <0.001), quality of life measured as BPI-SF pain intensity was maintained by 3.7 months more vs BSoC (HR 0.52, 95% CI, 0.43–0.63, nominal p-value with non-inferential analysis <0.001).

177Lu, lutetium; ADR, adverse drug reaction; AR, androgen receptor; BPI-SF; brief pain inventory (short form); BSoC, best standard of care; FACT-P, functional assessment of cancer therapy – prostate; mCRPC, metastatic castration-resistant prostate cancer; PSMA, prostate-specific membrane antigen; RLT, radioligand therapy.

References:

  1. Sartor O, et al. N Engl J Med 2021;385(12):1091–1103.
  2. Pluvicto® Great Britain Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/13965/smpc [Accessed March 2023].
AAA-PSMA-UK-0271 | March 2023
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