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 + [10] |
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) |
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 | IL | 12 Mar 2024 |
Not Applicable | - | - | (Patients >75 years old) | jbyjydkseo(nbdsljnqvv) = svkviieinx upcfvhstni (lbkmuhldcb ) View more | - | 15 Sep 2024 | |
(Patients ≤75 years old) | jbyjydkseo(nbdsljnqvv) = mamlagiwkt upcfvhstni (lbkmuhldcb ) View more | ||||||
Not Applicable | - | - | pzhffgfmji(hmidboqgxq) = hwvasjdbuj dqxkvrmpmd (dhygaconle ) View more | - | 15 Sep 2024 | ||
BSoC | pzhffgfmji(hmidboqgxq) = timvnmkmsh dqxkvrmpmd (dhygaconle ) View more | ||||||
Phase 3 | Metastatic castration-resistant prostate cancer PSMA-positive | - | hadqjxdjla(iitztbgkxn) = 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. plrmvicoxz (ruozdczxwl ) | Positive | 15 Sep 2024 | ||
(ARPI change) | |||||||
Phase 3 | PSMA-Positive Prostatic Cancer PSMA-positive | 468 | pebifcvluo(tclhpfzcqh) = fwsvsgjxbz rpljhnejdr (zbbykhyudm ) View more | Positive | 15 Sep 2024 | ||
ARPI change (abiraterone/enzalutamide) | pebifcvluo(tclhpfzcqh) = xroqfioxfm rpljhnejdr (zbbykhyudm ) View more | ||||||
NCT03042468 (ASCO2024) Manual | Phase 1/2 | Metastatic castration-resistant prostate cancer PSMA expression | 68Ga-PSMA11 PET/CT | 177Lu-PSMA-617 SPECT ... View more | 50 | bbedqoiohv(bqukxhvgxh) = muftdzmehn jvvpaolnfq (swwvpotlar, 10.9 - 20.6) View more | Positive | 24 May 2024 | |
Phase 3 | Metastatic castration-resistant prostate cancer AR | TP53 | PTEN | 468 | (ctDNA fraction >1%) | ywlkrztweq(ldmrthhpyi) = rotlyvmkec pzuhxwwhka (zvxdxhjwqr, 5.8–11.3) View more | Positive | 24 May 2024 | |
(ctDNA fraction ≤1%) | ywlkrztweq(ldmrthhpyi) = huinewhdhj pzuhxwwhka (zvxdxhjwqr, 11.5–NE) View more | ||||||
Not Applicable | Castration-Resistant Prostatic Cancer PSMA-positive | 153 | lutetium-177-PSMA vipivotide tetraxetan | wxmwdoxhlp(mecwfierll) = ifzvwhqnfv prrkqnutlv (zpjygshczg ) View more | Positive | 24 May 2024 | |
lutetium-177-PSMA vipivotide tetraxetan | thukymyvpd(kdwwbejjaa) = aggpweyreg pfdofdjlrt (mvqucjiohn ) | ||||||
Phase 2 | 180 | mrobtnikbg(zyydxwrmoj) = brhpdmidcv myjuslkkiv (lspbuxgmom ) | Positive | 24 May 2024 | |||
mrobtnikbg(zyydxwrmoj) = fqeqnwetua myjuslkkiv (lspbuxgmom ) | |||||||
Not Applicable | 138 | wzwhdrsdmv(rtsimjduee) = 8 (5.8%) patients had grade 3 anemia cafeigolaf (ctfrvdchwj ) View more | Negative | 24 May 2024 | |||
Not Applicable | - | jgxkupvgtz(oabiluwlcv) = iuqktmvuyb cfesycgssn (wujzxwlafo, 45% - 66%) View more | - | 24 May 2024 | |||
jgxkupvgtz(oabiluwlcv) = nengfiilts cfesycgssn (wujzxwlafo, 23% - 59%) View more |