Pluvicto
PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) in adult patients who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.
7.4 GBq (200 mCi) IV every 6 weeks for up to 6 doses
Infused slowly over approximately 3-5 minutes
Pre-treatment PSMA-positive imaging required (gallium Ga 68 gozetotide PET scan or similar)
Continue LHRH analogue or have had orchiectomy
Hydration: Encourage adequate hydration and frequent voiding for 48 hours post-dose
Injection: 7.4 GBq (200 mCi) per single-dose vial at calibration date and time
Pregnancy.
- Myelosuppression: Grade 3-4 anemia (13%), thrombocytopenia (8%), lymphopenia (8%), neutropenia (4%). Monitor CBC every 2 weeks × first 3 months, then every 4 weeks. Withhold for Grade ≥3.
- Renal Toxicity: Radiation to kidneys. Monitor creatinine and BUN regularly. D/C for Grade 3+ nephrotoxicity.
- Dry Mouth (Xerostomia): In 39%. Due to radiation to salivary glands (physiologic PSMA expression).
- Radiation Safety Precautions: Patient is radioactive post-dose. Minimize contact with others for 48 hours. Avoid pregnancy for 14 weeks post-last dose (males).
- Secondary Malignancies: Myelodysplastic syndrome and acute leukemia reported.
Fatigue (43%), dry mouth (39%), nausea (35%), anemia (32%), decreased appetite (21%), constipation (20%), vomiting (19%), musculoskeletal pain (18%), renal impairment (11%), thrombocytopenia (16%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Pluvicto is a radioligand therapy consisting of a PSMA-targeting ligand (vipivotide tetraxetan) conjugated to the beta-emitting radionuclide lutetium-177. PSMA (prostate-specific membrane antigen) is highly expressed on the surface of prostate cancer cells. Upon binding to PSMA, the radioligand is internalized, and lutetium-177 emits beta radiation (maximum energy 0.497 MeV, mean tissue penetration ~0.67 mm) that causes DNA double-strand breaks and cell death in PSMA-expressing cells and the surrounding microenvironment (crossfire effect).
Lu-177 physical half-life: 6.647 days. After IV administration, rapidly distributes to PSMA-expressing tissues. Approximately 60% of injected activity excreted in urine within 24 hours. Highest radiation-absorbed doses to salivary glands, kidneys, and bone marrow. Residual activity in tumor measurable on SPECT imaging for 1-2 weeks.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
- VISION — 177Lu-PSMA-617 + BSC vs. BSC in PSMA-positive mCRPC. Phase III, n=831.