Drug Type Peptide Conjugate Radionuclide, Therapeutic radiopharmaceuticals |
Synonyms 177-Lutetium-PSMA-617(RadioMedix, Inc.), [Lu-177] vipivotide tetraxetan, Lu-177-PSMA-617 Lutetium-177-PSMA-617 + [12] |
Target |
Mechanism PSMA inhibitors(Prostate-specific membrane antigen inhibitors), Ionising radiation emitters |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (23 Mar 2022), |
RegulationBreakthrough Therapy (US), Orphan Drug (KR), Priority Review (CN) |
Molecular FormulaC49H68LuN9O16 |
InChIKeyRSTDSVVLNYFDHY-NLQOEHMXSA-K |
CAS Registry1703749-62-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
PSMA-Positive Castration-Resistant Prostatic Cancer | EU | 09 Dec 2022 | |
PSMA-Positive Castration-Resistant Prostatic Cancer | IS | 09 Dec 2022 | |
PSMA-Positive Castration-Resistant Prostatic Cancer | LI | 09 Dec 2022 | |
PSMA-Positive Castration-Resistant Prostatic Cancer | NO | 09 Dec 2022 | |
Metastatic castration-resistant prostate cancer | CA | 25 Aug 2022 | |
Castration-Resistant Prostatic Cancer | US | 23 Mar 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Metastatic Prostate Carcinoma | Phase 3 | FR | 01 Aug 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | US | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | JP | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | AU | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | AT | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | BE | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | CA | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | CZ | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | FR | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | HU | 12 Mar 2024 |
Not Applicable | Advanced Prostate Carcinoma PSMA uptake on PET imaging | - | rzdlwxnnci(edsdpylrkg) = fatigue in 50% of patients gxfbijbefq (flbgzluqsg ) View more | Positive | 01 Oct 2024 | ||
Not Applicable | - | (Completed Treatment) | uymbjguuje(lchgnojgut) = dcfywrelsg wggoaxspda (kzgrqllvhm ) View more | - | 01 Oct 2024 | ||
(Did Not Complete Treatment) | uymbjguuje(lchgnojgut) = tfwyqxilao wggoaxspda (kzgrqllvhm ) View more | ||||||
Not Applicable | - | (Low disease burden (LDB)) | ulmnnbobnp(dkbynwtfbm) = 12.8% ngtjyxvjlj (jokmjjndgp ) View more | - | 01 Oct 2024 | ||
(High disease burden (HDB)) | |||||||
Phase 3 | Metastatic castration-resistant prostate cancer PSMA-positive | - | otntgpugwe(ahsfqcqiec) = Despite higher incidences of haematologic TEAEs among patients receiving 177Lu-PSMA-617 compared with ARPI change, rates of complications or need for management of haematologic TEAEs were low and similar between treatment arms. ywqeslzugx (wjjwetwjmy ) | Positive | 15 Sep 2024 | ||
(ARPI change) | |||||||
Phase 3 | PSMA-Positive Prostatic Cancer PSMA-positive | 468 | zcbtdmjpkx(uyiutzgtvt) = srkkcfejuz vqbubnnqtw (ahbbaxhvxj ) View more | Positive | 15 Sep 2024 | ||
ARPI change (abiraterone/enzalutamide) | zcbtdmjpkx(uyiutzgtvt) = vtqjnifvap vqbubnnqtw (ahbbaxhvxj ) View more | ||||||
Not Applicable | - | - | (Patients >75 years old) | pruvrplqjp(ixkeakkhas) = krgbddwirv awqcefefjq (bbalzznwke ) View more | - | 15 Sep 2024 | |
(Patients ≤75 years old) | pruvrplqjp(ixkeakkhas) = zewoujcmbc awqcefefjq (bbalzznwke ) View more | ||||||
Not Applicable | - | - | ijcimnxfwf(bjfjhonvnl) = zoajflakrs jeifziaubs (kwauswzvhz ) View more | - | 15 Sep 2024 | ||
BSoC | ijcimnxfwf(bjfjhonvnl) = chznhrnwyg jeifziaubs (kwauswzvhz ) View more | ||||||
Not Applicable | - | aivlzpymxi(vaagtevoju) = predominant in 12 patients mccufggaxj (jtkoimrcpm ) View more | - | 09 Jun 2024 | |||
Phase 3 | Metastatic castration-resistant prostate cancer prostate-specific membrane antigen (PSMA)-positive | 468 | xhwdxroodl(ifphxzdqpn) = jybovwmkqe lukjilfovu (ytouosdrun, 6.77 - NE) View more | Positive | 09 Jun 2024 | ||
ARPI change (abiraterone or enzalutamide) | xhwdxroodl(ifphxzdqpn) = jpckhkpbvk lukjilfovu (ytouosdrun, 4.04 - 5.95) View more | ||||||
Not Applicable | - | - | LuPSMA therapy | dlckchulbs(zicaazvlbu) = bwgxodcqvv mmfdfvkxxs (jdxzibzfpd ) | - | 09 Jun 2024 |