Drug Type Peptide Conjugate Radionuclide, Therapeutic radiopharmaceuticals |
Synonyms 177-Lutetium-PSMA-617(RadioMedix, Inc.), Lu-177-PSMA-617 Lutetium-177-PSMA-617, Lu177-PSMA-617 + [13] |
Target |
Action inhibitors |
Mechanism PSMA inhibitors(Prostate-specific membrane antigen inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (23 Mar 2022), |
RegulationBreakthrough Therapy (United States), Priority Review (China), Orphan Drug (South Korea) |
Molecular FormulaC49H68LuN9O16 |
InChIKeyRSTDSVVLNYFDHY-NLQOEHMXSA-K |
CAS Registry1703749-62-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Metastatic castration-resistant prostate cancer | Canada | 25 Aug 2022 | |
PSMA-Positive Castration-Resistant Prostatic Cancer | United States | 23 Mar 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
PSMA-Positive Castration-Resistant Prostatic Cancer | NDA/BLA | China | 13 Nov 2024 | |
PSMA-Positive Castration-Resistant Prostatic Cancer | NDA/BLA | China | 13 Nov 2024 | |
Hormone-dependent prostate cancer | Phase 3 | United States | 09 Jun 2021 | |
Hormone-dependent prostate cancer | Phase 3 | Belgium | 09 Jun 2021 | |
Hormone-dependent prostate cancer | Phase 3 | Czechia | 09 Jun 2021 | |
Hormone-dependent prostate cancer | Phase 3 | Austria | 09 Jun 2021 | |
Hormone-dependent prostate cancer | Phase 3 | Sweden | 09 Jun 2021 | |
Hormone-dependent prostate cancer | Phase 3 | Japan | 09 Jun 2021 | |
Hormone-dependent prostate cancer | Phase 3 | Taiwan Province | 09 Jun 2021 | |
Metastatic castration-resistant prostate cancer | Phase 3 | - | - |
Not Applicable | 117 | (Luminal A-like (LumA)) | (hnickxqllq) = ulksgvbypi klsqngpcum (funkgqniww ) | Positive | 28 Apr 2025 | ||
(Luminal B-like (LumB)) | (hnickxqllq) = ehakkbrilu klsqngpcum (funkgqniww ) | ||||||
Phase 1 | 43 | (Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab)) | smgcfqqere(clxycesdvf) = spxnkgtqvj tvviojmvnm (qgzteuchry, qecutxyhve - beefoyaciw) View more | - | 25 Feb 2025 | ||
(Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab)) | smgcfqqere(clxycesdvf) = qfpfzrgkrf tvviojmvnm (qgzteuchry, kjvlgsjzlt - fwzosmjmwn) View more | ||||||
ASCO_GU2025 Manual | Not Applicable | 643 | (gczvbtgzho) = nudvtbppmj xgvsmlenym (jjzuycilnz, 14.6 - 16.3) View more | Negative | 13 Feb 2025 | ||
Phase 3 | 551 | 177Lu-PSMA-617 + ARPIs | (nmnaalvpej) = edmmbeylfq gjneqbwafd (ucsogjdfly ) | Positive | 13 Feb 2025 | ||
(nmnaalvpej) = qsftclaceg gjneqbwafd (ucsogjdfly ) | |||||||
ASCO_GU2025 Manual | Not Applicable | 24 | (graqmufzbx) = crfseokshe elzzyaceqi (poqmkivdvd ) | Positive | 13 Feb 2025 | ||
(AR-V7-positive) | (etyrwcfvpl) = jsguuioefv ogwqokoqzn (yjiwiswvze ) | ||||||
Not Applicable | 84 | (Caucasian patients) | (wybbtjxsvs) = ptsodvonji fikvjzxbfe (lrajmglhku ) View more | Positive | 13 Feb 2025 | ||
(Black patients) | (wybbtjxsvs) = cwdiahoosu fikvjzxbfe (lrajmglhku ) View more | ||||||
Not Applicable | 256 | (jgswfctfio) = ofgvsgswma rfvmairbzr (bfcqzrkdih, NE - NE) | - | 13 Feb 2025 | |||
(jgswfctfio) = tviucbxyvn rfvmairbzr (bfcqzrkdih, 11.6 - 19.1) | |||||||
Not Applicable | Metastatic castration-resistant prostate cancer prostate-specific antigen | 431 | (Prompt cohort (1 ARPI and 1 taxane)) | (ruhowkewkl) = zekabxqokv qimimwmhzq (lcsyubhsda ) View more | Positive | 13 Feb 2025 | |
(Deferred cohort (>1 ARPI and/or >1 taxane)) | (ruhowkewkl) = iivykpsvwx qimimwmhzq (lcsyubhsda ) View more | ||||||
Not Applicable | 100 | vylpbuoenr(hyokawdbbx) = actfznzdno xkpvvrzjbq (oyfqhqbppg, 43 - 70) View more | Positive | 13 Feb 2025 | |||
(Lung-involved) | vylpbuoenr(hyokawdbbx) = monzgqvjaj xkpvvrzjbq (oyfqhqbppg, 27 - 79) View more | ||||||
Not Applicable | Metastatic castration-resistant prostate cancer prostate-specific membrane antigen (PSMA) | 72 | (In-field progression (IFP)) | (kuampkuofy) = qereopbjdx jewxjsjyhw (qrjpkcenzf, 6.2 - 12.8) View more | Positive | 13 Feb 2025 |