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Lutetium-177 (lutetium-177)
Lutetium-177 (generic name: lutetium-177) is a mCRPC drug developed by Pfizer Inc.. It is currently in preclinical development.
mCRPC
Lutetium-177 is a radioactive therapeutic agent that delivers targeted cancer-killing radiation directly to tumor cells. It works by binding to specific proteins on cancer cells and emitting radiation that destroys them from within. This approach allows for effective treatment while minimizing exposure to healthy tissue.
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Baseline preclinical → approval rate
+5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2036–2040 | — |
| EMA | EU | 2037–2041 | +0.7 yr |
| MHRA | GB | 2037–2041 | +0.7 yr |
| Health Canada | CA | 2037–2042 | +0.9 yr |
| TGA | AU | 2037–2042 | +1.2 yr |
| PMDA | JP | 2037–2042 | +1.5 yr |
| NMPA | CN | 2038–2043 | +2.3 yr |
| MFDS | KR | 2037–2042 | +1.4 yr |
| CDSCO | IN | 2037–2043 | +1.8 yr |
| ANVISA | BR | 2038–2043 | +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 | lutetium-177 |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | mCRPC |
| Therapeutic area | Oncology |
| Phase | preclinical |
Mechanism of action
Lutetium-177 is a radioactive isotope used in targeted cancer therapy. It works by being attached to molecules that seek out and bind to specific proteins found on the surface of cancer cells. Once these molecules find their targets, they deliver the Lutetium-177 directly to the tumor, where the radioactive element can do its work. Once bound to cancer cells, Lutetium-177 releases radiation in the form of particles that cause damage to the cell's DNA and other critical structures. This radiation is strong enough to kill cancer cells but works locally—meaning the damaging radiation mainly affects the cancer cells it's attached to rather than spreading throughout the body. This targeted approach offers an advantage over traditional chemotherapy: it can attack cancer cells while sparing many healthy cells that don't have the target protein. The radiation dose is concentrated where it's needed most, potentially making treatment more effective and causing fewer side effects compared to treatments that attack all cells indiscriminately.
Approved indications
Pipeline indications
- Metastatic Castration Sensitive Prostate Cancer (mCSPC) — preclinical
Common side effects
Key clinical trials
- Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finlan (N/A)
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:
- Lutetium-177 CI brief — competitive landscape report
- Lutetium-177 updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Lutetium-177
What is Lutetium-177?
How does Lutetium-177 work?
Who makes Lutetium-177?
What is the generic name of Lutetium-177?
What drug class is Lutetium-177 in?
What development phase is Lutetium-177 in?
Related
- Drug class: All mCRPC drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing