Lutetium Lu-177 vipivotide tetraxetan

At a glance

Overview

Pluvicto combines a PSMA-binding ligand, a metal-binding chelator and the radioactive isotope lutetium-177. It is a radioligand cancer medicine rather than a conventional hormone peptide. Patient selection requires an appropriate PSMA-positive imaging assessment and attention to disease stage and previous therapy. The current US label covers metastatic androgen pathway modulation-naïve or sensitive disease with an ARPI, and specified resistant disease after an ARPI. The latter includes patients considered suitable to delay taxane chemotherapy or previously treated with a taxane. It is administered by teams equipped for radiopharmaceutical treatment and radiation protection.

Supporting sources [1] [2] [3] [4]

How it works

The ligand binds prostate-specific membrane antigen on target cells. Lutetium-177 then emits beta radiation that damages DNA in PSMA-expressing cells and nearby tissue, potentially causing cell death. PSMA expression is not exclusive to tumor tissue, so targeting does not eliminate exposure of normal organs. Renal elimination, bone-marrow effects and cumulative radiation exposure remain clinically relevant despite the treatment’s molecular targeting.

Supporting sources [1] [2] [3] [4]

How did the indication change in 2026?

FDA approved Pluvicto with an ARPI for adults with PSMA-positive metastatic androgen pathway modulation-naïve or sensitive prostate cancer, previously termed metastatic hormone-sensitive disease. The resistant-disease indication also remains: previous ARPI therapy plus suitability to delay taxane chemotherapy or prior taxane treatment.

Supporting sources [1] [2]

Which outcomes have been demonstrated?

VISION established progression and overall-survival benefit in a previously treated resistant-disease population. PSMAfore supported earlier use before taxane chemotherapy through improved radiographic progression-free survival; its overall-survival comparison was not statistically significant. PSMAddition supported the 2026 hormone-sensitive indication through improved radiographic progression-free survival. These populations and endpoints are different.

Supporting sources [2] [3] [4]

What does targeted radiation still put at risk?

The label warns about cumulative radiation exposure, severe myelosuppression, kidney toxicity, embryo-fetal harm and male infertility. Fatigue, dry mouth and nausea are among common adverse effects. Blood counts, kidney function and radiation-protection procedures are integral to treatment rather than optional additions.

Supporting sources [1]

Is a PSMA scan the treatment itself?

No. PSMA imaging helps identify suitable disease and select patients, while Pluvicto delivers therapeutic radiation. A positive scan alone does not establish eligibility without the relevant clinical and treatment-history criteria. The radiopharmaceutical must be handled in an appropriately equipped clinical service.

Supporting sources [1]