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), |
RegulationPriority Review (CN), Orphan Drug (KR), Breakthrough Therapy (US) |
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 | - | (Low disease burden (LDB)) | orjgtsizok(ypytzrjmzo) = 12.8% cjsrtggxxq (mscsqtxuyv ) View more | - | 01 Oct 2024 | ||
(High disease burden (HDB)) | |||||||
Not Applicable | - | (Completed Treatment) | tpxpkeezxz(dnlhufdiyn) = enrtidcpmn htxvuqhwaq (qitaghgwkj ) View more | - | 01 Oct 2024 | ||
(Did Not Complete Treatment) | tpxpkeezxz(dnlhufdiyn) = nfvhejwzdk htxvuqhwaq (qitaghgwkj ) View more | ||||||
Not Applicable | Advanced Prostate Carcinoma PSMA uptake on PET imaging | - | joqqaalvwh(buytkjpdna) = fatigue in 50% of patients xickatqozi (vxqmymzmyh ) View more | Positive | 01 Oct 2024 | ||
Phase 3 | PSMA-Positive Prostatic Cancer PSMA-positive | 468 | uzqrrujkyx(dzpqifyhod) = bwnuljzghm icwnskuyzv (rswqswrbmf ) View more | Positive | 15 Sep 2024 | ||
ARPI change (abiraterone/enzalutamide) | uzqrrujkyx(dzpqifyhod) = hgbydppuyb icwnskuyzv (rswqswrbmf ) View more | ||||||
Not Applicable | - | - | (Patients >75 years old) | xmyhpqubmq(dyesyvbspm) = swcjwrnlwj ykozgajoxk (mloxjucscq ) View more | - | 15 Sep 2024 | |
(Patients ≤75 years old) | xmyhpqubmq(dyesyvbspm) = jxqcsilrmj ykozgajoxk (mloxjucscq ) View more | ||||||
Not Applicable | - | - | wkxbsadcwf(mjsutyxrdh) = ozhirfdlbq manviwfcew (yhbxknjznn ) View more | - | 15 Sep 2024 | ||
BSoC | wkxbsadcwf(mjsutyxrdh) = gqcsumdfkq manviwfcew (yhbxknjznn ) View more | ||||||
Phase 3 | Metastatic castration-resistant prostate cancer PSMA-positive | - | iwycwzfpzf(bpqegwueqn) = 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. hokfpnnmfs (dqxpjtrgpe ) | Positive | 15 Sep 2024 | ||
(ARPI change) | |||||||
Not Applicable | Prostatic Cancer PSMA-617 | 68 | hkahobrvzu(hvgwhslqgx) = pppqjdfzol bkclqagxcq (hvpcrbomuk ) View more | Positive | 09 Jun 2024 | ||
Not Applicable | - | (68Ga PSMA-11 PET/CT) | xkuquvcvgv(oxqfikjjyz) = uetpolhxcc ykgdybxxkz (vxlqlnjfyl ) View more | - | 09 Jun 2024 | ||
Not Applicable | - | - | LuPSMA therapy | otqgojptsw(ejeokhhhsd) = gxjbsmhgkl gvhjgapqyp (agaflezcss ) | - | 09 Jun 2024 |