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Lu-177 PSMA-617
Lu-177 PSMA-617 is a Radioligand therapy Small molecule drug developed by Radboud University Medical Center. It is currently in Phase 3 development for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression. Also known as: Lutetium-177 Prostate Specific Membrane Antigen.
Lu-177 PSMA-617 is a radioligand that binds to prostate-specific membrane antigen (PSMA) on cancer cells and delivers targeted radiation to kill them.
Lu-177 PSMA-617 is a radioligand that binds to prostate-specific membrane antigen (PSMA) on cancer cells and delivers targeted radiation to kill them. Used for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Lu-177 PSMA-617 |
|---|---|
| Also known as | Lutetium-177 Prostate Specific Membrane Antigen |
| Sponsor | Radboud University Medical Center |
| Drug class | Radioligand therapy |
| Target | PSMA (prostate-specific membrane antigen) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Lu-177 PSMA-617 consists of lutetium-177, a beta-emitting radioisotope, conjugated to a small molecule ligand that specifically targets PSMA, a cell-surface antigen highly expressed on prostate cancer cells. Once bound to PSMA-expressing tumors, the radioisotope delivers localized radiation that damages cancer cell DNA, leading to cell death. This approach enables targeted radiotherapy with reduced systemic toxicity compared to conventional chemotherapy.
Approved indications
- Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression
Common side effects
- Hematologic toxicity (anemia, thrombocytopenia, leukopenia)
- Xerostomia (dry mouth)
- Nausea
- Fatigue
- Kidney toxicity
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)
- Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy (PHASE2, PHASE3)
- Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy (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)
- A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (PHASE2)
- A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients
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:
- Lu-177 PSMA-617 CI brief — competitive landscape report
- Lu-177 PSMA-617 updates RSS · CI watch RSS
- Radboud University Medical Center portfolio CI
Frequently asked questions about Lu-177 PSMA-617
What is Lu-177 PSMA-617?
How does Lu-177 PSMA-617 work?
What is Lu-177 PSMA-617 used for?
Who makes Lu-177 PSMA-617?
Is Lu-177 PSMA-617 also known as anything else?
What drug class is Lu-177 PSMA-617 in?
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What does Lu-177 PSMA-617 target?
Related
- Drug class: All Radioligand therapy drugs
- Target: All drugs targeting PSMA (prostate-specific membrane antigen)
- Manufacturer: Radboud University Medical Center — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression
- Also known as: Lutetium-177 Prostate Specific Membrane Antigen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing