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
Pluvicto mechanism of action
Pluvicto targets PSMA-positive cells, including prostate cancer cells.2
Safety profile and efficacy
The efficacy and safety profile of Pluvicto + BSoC were assessed in the VISION trial.1
Dosing and administration
Pluvicto is a ready-to-use solution administered intravenously.2
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:
- Sartor O, et al. N Engl J Med 2021;385(12):1091–1103.
- Pluvicto® Great Britain Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/13965/smpc [Accessed March 2023].