Last reviewed · How we verify
Pluvicto
At a glance
| Generic name | Pluvicto |
|---|---|
| Also known as | Lu177-PSMA |
| Sponsor | VA Office of Research and Development |
| Target | Prostate-specific antigen |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- PSMA-positive metastatic castration-resistant prostate cancer
Common side effects
- Decreased lymphocytes
- Decreased hemoglobin
- Fatigue
- Dry mouth
- Decreased platelets
- Decreased estimated glomerular filtration rate
- Nausea
- Decreased neutrophils
- Decreased calcium
- Decreased sodium
- Increased aspartate aminotransferase
- Increased alkaline phosphatase
Serious adverse events
- Anemia
- Urinary tract infection
- Hemorrhage
- Sepsis
- COVID-19 pneumonia
- Cardiac arrest
- Intestinal ischemia
- Thrombocytopenia
- Acute kidney injury
- Pancytopenia
Key clinical trials
- 177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer (PHASE2)
- Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease (PHASE2)
- 177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (PHASE3)
- 177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer (PHASE1)
- Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan (PHASE2)
- Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (PHASE2)
- An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) (PHASE3)
- Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pluvicto CI brief — competitive landscape report
- Pluvicto updates RSS · CI watch RSS
- VA Office of Research and Development portfolio CI