更新于：2024-11-14
Lutetium (177 Lu) Vipivotide Tetraxetan
镥[177Lu] 特昔维匹肽
更新于：2024-11-14
概要
基本信息
药物类型 多肽偶联核素、治疗用放射药物 |
别名 177-Lutetium-PSMA-617(RadioMedix, Inc.)、[Lu-177] vipivotide tetraxetan、Lu-177-PSMA-617 Lutetium-177-PSMA-617 + [12] |
靶点 |
作用机制 PSMA抑制剂(前列腺癌特异性膜抗原抑制剂)、电离辐射发射源 |
在研适应症 |
非在研适应症 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2022-03-23), |
最高研发阶段(中国)申请上市 |
特殊审评突破性疗法 (美国)、优先审评 (中国)、孤儿药 (韩国) |
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结构
分子式C49H68LuN9O16 |
InChIKeyRSTDSVVLNYFDHY-NLQOEHMXSA-K |
CAS号1703749-62-5 |
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68
项与 镥[177Lu] 特昔维匹肽 相关的临床试验STARLiT: STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer: A Phase I/II Trial
Comparison of Changes in Tumor Burden (Toral Tumor Volume [TMTV] and Total Lesion Activity [TLA]) in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in the Monitoring of Metastatic Castration-resistant Prostate Cancer Treated With 177Lutetium-PSMA-617
A Phase 2 Study of Biomarker-Modulated PSMA Theranostics
100 项与 镥[177Lu] 特昔维匹肽 相关的临床结果
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100 项与 镥[177Lu] 特昔维匹肽 相关的转化医学
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100 项与 镥[177Lu] 特昔维匹肽 相关的专利（医药）
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412
项与 镥[177Lu] 特昔维匹肽 相关的文献（医药）2024-12-01CLINICAL NUCLEAR MEDICINE
177Lu-PSMA-617 Radioligand Therapy in Patient With Prostate Cancer Sciatic Nerve Metastasis
Article
作者: Thureau, Sébastien ; Edet-Sanson, Agathe ; Tonnelet, David ; Augusto, Laetitia ; Cabourg, Marine
Abstract:
Patients with metastatic castration-resistant prostate cancer usually have lymph nodes and bone metastasis. We present a rare case of a 51-year-old patient with metastatic castration-resistant prostate cancer who complained of left truncated sciatica and diffuse bone pain and who was referred for 177Lu-prostate-specific membrane antigen (PSMA) screening. Pretreatment 68Ga-PSMA showed left sciatic nerve and multiple bone uptake. Patient underwent stereotactic radiotherapy on the sciatic nerve metastasis (30 Gy in 6 fractions of 5 Gy) before 7.4 GBq of 177Lu-PSMA infusions. Left truncated sciatica disappeared after stereotactic radiotherapy. No additional toxicity was added to the sciatic nerve from 177Lu-PSMA after stereotactic radiotherapy.
2024-12-01Current radiopharmaceuticals
177Lu-PSMA-617 Radioligand Treatment in Elderly Patients with Metastatic Castration-resistant Prostate Cancer: Therapeutic Efficacy and Safety Assessment
Article
作者: Sahin, Ertan ; Okuyan, Merve ; Cimen, Ufuk ; Elboga, Umut ; Cayirli, Yusuf Burak
Objective::
This study aimed to evaluate the therapeutic efficacy and safety of
177Lutetium-Prostate Specific Membrane Antigen (177Lu-PSMA-617) radioligand treatment
(RLT) in metastatic castration-resistant prostate cancer (mCRPC) patients with aged older than
75 years.
Methods::
A total of 37 patients with mCRPC aged older than 75 years treated with 177Lu-
PSMA-617 were included in this study.
::
Pre-therapy and post-therapy biochemical, metabolic, and clinical response results and Hb,
TLC, platelet, serum creatinine and bilirubin levels were checked to evaluate the therapeutic
efficacy and toxicity profile. The Common Terminology Criteria for Adverse Events was used
for grading adverse events caused by 177Lu-PSMA-617 treatment.
Results::
The mean age of the patients included in the study was 79.8±2.9 (76-92). The number
of 177Lu-PSMA-617 treatment cycles ranged from two to four, and the mean administered radioactivity
dose was 5.6±0.8 GBq per cycle. Partial biochemical response (PR) and partial metabolic
response (PMR) were observed in 11 (29.7%) and 15 (40.6%) patients after treatment,
respectively. Although improvement in ECOG scores was observed in 5 (13.5%) patients after
treatment, it was not statistically significant. Grade 2 and 3 Hb toxicity was observed in 10
(27%) and 2 (5.4%) patients, respectively. Grade 2 leukocytopenia in six patients, Grade 1
thrombocytopenia in six patients, and Grade 2 serum creatinine toxicity in five patients were
seen after the treatment. On the other hand, no patients developed liver toxicity and grade 3 or 4
leukocytopenia, thrombocytopenia or creatinine toxicity.
Conclusion::
177Lu-PSMA-617 treatment was a safe and effective treatment option for properly
selected elderly mCRPC patients.
2024-12-01APPLIED RADIATION AND ISOTOPES
The production and separation of 161Tb with high specific activity at the University of Utah
Article
作者: Wang, Meng-Jen (Vince) ; Holiski, Connor K. ; Sjoden, Glenn E. ; Holiski, Connor K ; Hennkens, Heather M. ; Monte, Peñafrancia F ; Embree, Mary F. ; Monte, Peñafrancia F. ; Bender, Aidan A ; Bender, Aidan A. ; Sjoden, Glenn E ; Wang, Meng-Jen Vince ; Hennkens, Heather M ; Mastren, Tara ; Embree, Mary F
Targeted radiotherapy (TRT) is an increasingly prominent area of research in nuclear medicine, particularly in the context of treating cancerous tumors. One radionuclide of considerable interest for TRT is terbium-161 (t1/2 = 6.95 days), which undergoes beta emission and shares similar decay properties as 177Lu (FDA-approved as LUTATHERA® and PLUVICTO®). Besides beta emission, 161Tb also emits a significant number of conversion and Auger electrons further enhancing its therapeutic potential. Terbium-161 can be produced using nuclear reactors through an indirect neutron capture reaction, G64160dn,γG64161d→3.66min,β-T65161b, from 160Gd targets. However, a key challenge in utilizing 161Tb for TRT lies in effectively separating target and product materials to attain high specific activity for radiolabeling. Here, we detail the production of no-carrier added 161Tb using low flux research reactors (mean thermal (<0.625 eV) neutron flux: 1.356×1012n∙cm-2∙s-1) like the University of Utah TRIGA Reactor, using enriched 160Gd2O3 targets (1.5 ± 0.3 μCi of 161Tb per mg of 160Gd target per hour of irradiation). We also developed a separation technique based on cation exchange and extraction chromatography, suitable for mCi level irradiations with targets exceeding 200 mg. In a simulated full-scale irradiation, 161Tb was successfully isolated from large mass targets using cation exchange (AG 50W-X8, with 2-hydroxyisobutyric acid at 70 mM, pH 4.75) and extraction chromatography (LN Resin, 0.5-0.75 M HNO3) methods. This resulted in high apparent molar activities of [161Tb]Tb-DOTA (113 ± 3 MBq/nmol), demonstrating high purity 161Tb relevant for potential future preclinical applications.
610
项与 镥[177Lu] 特昔维匹肽 相关的新闻（医药）2024-11-14
抗体药物偶联物并购放射疗法优先审批申请上市
2024-11-13
100 项与 镥[177Lu] 特昔维匹肽 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| PSMA阳性去势抵抗性前列腺癌 | 欧盟 | 2022-12-09 | |
| PSMA阳性去势抵抗性前列腺癌 | 冰岛 | 2022-12-09 | |
| PSMA阳性去势抵抗性前列腺癌 | 列支敦士登 | 2022-12-09 | |
| PSMA阳性去势抵抗性前列腺癌 | 挪威 | 2022-12-09 | |
| 转移性去势抵抗性前列腺癌 | 加拿大 | 2022-08-25 | |
| 去势抵抗性前列腺癌 | 美国 | 2022-03-23 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 转移性前列腺癌 | 临床3期 | 法国 | 2024-08-01 | |
| 寡转移性前列腺癌 | 临床3期 | 美国 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 日本 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 澳大利亚 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 奥地利 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 比利时 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 加拿大 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 捷克 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 法国 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 匈牙利 | 2024-03-12 |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | (Completed Treatment) | 鹽繭膚夢糧範襯衊衊鏇(鹹蓋襯範選簾齋憲廠淵) = 鬱醖製憲蓋鹽衊廠顧蓋 構鬱餘構繭鑰構壓鏇獵 (襯簾糧鹹簾醖廠鑰蓋餘 ) 更多 | - | 2024-10-01 | ||
(Did Not Complete Treatment) | 鹽繭膚夢糧範襯衊衊鏇(鹹蓋襯範選簾齋憲廠淵) = 鹹觸獵網繭鹽餘簾膚選 構鬱餘構繭鑰構壓鏇獵 (襯簾糧鹹簾醖廠鑰蓋餘 ) 更多 | ||||||
N/A | - | (Low disease burden (LDB)) | 糧築糧鑰簾鑰衊艱積壓(選襯簾積願製醖淵鹹餘) = 12.8% 製襯鹽窪選鬱鹹壓鏇製 (範淵壓鹹餘願獵衊膚鹽 ) 更多 | - | 2024-10-01 | ||
(High disease burden (HDB)) | |||||||
N/A | 晚期前列腺癌 PSMA uptake on PET imaging | - | 獵衊鹹淵鑰醖製獵築鹹(鏇壓製構構鹹顧製築鬱) = fatigue in 50% of patients 築齋廠網簾窪築壓襯製 (鏇選廠糧繭醖鹹醖窪蓋 ) 更多 | 积极 | 2024-10-01 | ||
N/A | - | - | 醖壓醖獵構襯鑰築範網(構鑰顧蓋觸製簾構鬱願) = 壓遞糧鑰網壓膚遞網醖 襯繭齋衊鹽構壓獵願壓 (網鑰選襯遞廠齋鹹鬱選 ) 更多 | - | 2024-09-15 | ||
BSoC | 醖壓醖獵構襯鑰築範網(構鑰顧蓋觸製簾構鬱願) = 壓夢淵夢齋鬱願膚窪艱 襯繭齋衊鹽構壓獵願壓 (網鑰選襯遞廠齋鹹鬱選 ) 更多 | ||||||
临床3期 | 转移性去势抵抗性前列腺癌 PSMA-positive | - | 獵鹹鏇鏇鏇鑰構積網憲(壓鬱鹽艱艱鹹簾憲衊構) = 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. 網範餘範廠醖襯網齋糧 (簾鬱醖窪觸艱網顧餘築 ) | 积极 | 2024-09-15 | ||
(ARPI change) | |||||||
临床3期 | PSMA阳性前列腺癌 PSMA-positive | 468 | 構壓範糧壓繭壓齋淵構(餘獵範選憲鏇壓鑰壓鏇) = 淵衊築襯遞醖範膚選遞 積鹽餘窪蓋艱鏇夢顧顧 (衊鏇範壓觸選簾鹹醖築 ) 更多 | 积极 | 2024-09-15 | ||
ARPI change (abiraterone/enzalutamide) | 構壓範糧壓繭壓齋淵構(餘獵範選憲鏇壓鑰壓鏇) = 窪鬱糧網壓選蓋鏇膚窪 積鹽餘窪蓋艱鏇夢顧顧 (衊鏇範壓觸選簾鹹醖築 ) 更多 | ||||||
N/A | - | - | (Patients >75 years old) | 艱膚鹽壓遞夢網製艱齋(廠網遞餘範獵膚積繭遞) = 觸壓衊襯餘鹹積夢膚鑰 憲鹹壓壓觸製鏇壓鏇鬱 (積鬱範顧選憲醖積觸繭 ) 更多 | - | 2024-09-15 | |
(Patients ≤75 years old) | 艱膚鹽壓遞夢網製艱齋(廠網遞餘範獵膚積繭遞) = 齋鹹糧鹽廠積鹹膚艱夢 憲鹹壓壓觸製鏇壓鏇鬱 (積鬱範顧選憲醖積觸繭 ) 更多 | ||||||
N/A | - | - | LuPSMA therapy | 蓋繭積襯網遞範顧觸鏇(願衊鑰齋範遞窪窪襯壓) = 淵窪繭獵網衊製觸廠衊 遞網窪廠構齋繭鏇鏇餘 (範網獵鹽築憲鏇襯蓋鹹 ) | - | 2024-06-09 | |
临床2期 | PSA | 85 | 醖構築憲壓衊廠鑰醖願(齋選糧憲餘醖鑰鏇願鹹) = 積製衊簾襯夢衊襯鹹範 簾觸壓願蓋築獵鬱淵窪 (鹽遞淵網醖鏇窪齋艱築 ) | 积极 | 2024-06-09 | ||
N/A | - | (Standard treatment regimen) | 選觸餘齋齋遞選範醖製(鑰夢範構蓋鹹醖壓鏇醖) = 製鹹選繭衊願範膚築廠 夢艱壓糧簾淵憲鏇鏇憲 (壓糧襯網艱網衊憲憲製 ) 更多 | - | 2024-06-09 | ||
(Fractionation schedules) | 選觸餘齋齋遞選範醖製(鑰夢範構蓋鹹醖壓鏇醖) = 鹽選糧蓋鹹壓壓鑰鑰餘 夢艱壓糧簾淵憲鏇鏇憲 (壓糧襯網艱網衊憲憲製 ) 更多 |
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