[177Lu]Lu-PSMA-617 (PluvictoTM): The First FDA-Approved Radiotherapeutical for Treatment of Prostate Cancer

Hennrich, Ute; Eder, Matthias

doi:10.3390/ph15101292

Cited by 122 publications

(79 citation statements)

References 44 publications

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“…The latter is the only score endorsed by the EANM guidelines and seems to pave the way for its introduction in large clinical trials [ 11 ]. However, considering the recent approvement of [ 177 Lu]Lu-PSMA RLT for PSMA-positive mCRPCa patients [ 69 ], neither PSMA-RADS nor miTNM include treatment recommendations for this therapy needing warranting improvements. In this scenario, the recently proposed Pro-PET score combined both PSMA-ligand and [ 18 F]FDG PET/CT performed before RLT to improve patients’ selection and serving as a prognostic marker.…”

Section: Discussionmentioning

confidence: 99%

PET Criteria by Cancer Type from Imaging Interpretation to Treatment Response Assessment: Beyond FDG PET Score

Dondi

Lazzarato

Gorica

et al. 2023

Life

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Background: in recent years, the role of positron emission tomography (PET) and PET/computed tomography (PET/CT) has emerged as a reliable diagnostic tool in a wide variety of pathological conditions. This review aims to collect and review PET criteria developed for interpretation and treatment response assessment in cases of non-[18F]fluorodeoxyglucose ([18F]FDG) imaging in oncology. Methods: A wide literature search of the PubMed/MEDLINE, Scopus and Google Scholar databases was made to find relevant published articles about non-[18F]FDG PET response criteria. Results: The comprehensive computer literature search revealed 183 articles. On reviewing the titles and abstracts, 149 articles were excluded because the reported data were not within the field of interest. Finally, 34 articles were selected and retrieved in full-text versions. Conclusions: available criteria are a promising tool for the interpretation of non-FDG PET scans, but also to assess the response to therapy and therefore to predict the prognosis. However, oriented clinical trials are needed to clearly evaluate their impact on patient management.

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Section: Discussionmentioning

confidence: 99%

PET Criteria by Cancer Type from Imaging Interpretation to Treatment Response Assessment: Beyond FDG PET Score

Dondi

Lazzarato

Gorica

et al. 2023

Life

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“…In recent years, we have been witnessing an impressive development in the field of targeted radionuclide therapy, firstly with the approval of 223 Ra-therapy for PCa therapy, then followed by the authorization of [ 177 Lu]Lu-oxodotreotide for the management of neuroendocrine tumors (NET) and, even more recently, by the implementation of [ 177 Lu]Lu-PSMA-617 for mCRPC [ 14 , 29 , 30 , 31 ].…”

Section: Discussionmentioning

confidence: 99%

“…On the therapeutic side, the international, open-label, phase 3 VISION proved that mCRPC subjects treated with [ 177 Lu]Lu-PSMA-617 had both longer imaging-based progression-free survival and overall survival with respect to subjects submitted to the best standard of care [ 13 ]. As a result, [ 177 Lu]Lu-PSMA-617 (Pluvicto TM ) has been recently FDA-approved for the radioligand therapy (RLT) of mCRPC, previously tested for PSMA-expression by PSMA PET/CT [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

DNA Damage Repair Defects and Targeted Radionuclide Therapies for Prostate Cancer: Does Mutation Really Matter? A Systematic Review

Filippi

Palumbo²,

Bagni³

et al. 2022

Life

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The aim of the present review was to assess the impact of DNA damage repair (DDR) mutations on response and outcome of patients (pts) affected by advanced prostate cancer (PCa) submitted to radionuclide therapies with [223Ra]RaCl2 (223Ra-therapy) or prostate specific membrane antigen (PSMA) ligands. A systematic literature search according to PRISMA criteria was made by using two main databases. Only studies published up until to October 2022 in the English language with ≥10 enrolled patients were selected. Seven studies including 326 pts, of whom 201 (61.6%) harboring DDR defects, were selected. The majority of selected papers were retrospective and four out of seven (57.1%) had small sample size (<50 pts). Three out of seven (42.8%) studies reported a more favorable outcome (overall or progression free survival) after therapy with alpha emitters (223Ra-therapy or [225Ac]Ac-PSMA-617) in subjects with DDR defects with respect to those without mutations. In two studies employing alpha or beta emitters ([177Lu]/[225Ac]-PMSA), no significant benefit was registered in pts harboring DDR defects. In all but one paper, no significant difference in response rate was reported among pts with or without DDR mutations. Although preliminary and biased by the retrospective design, preliminary data suggest a trend towards a longer survival in PCa pts harboring DDR defects submitted to radionuclide targeted therapy with alpha emitters.

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“…Most radiopharmaceuticals used and developed today for RNT contain β − -emitting radionuclides, among which lutetium-177 seems to be one of the most promising, due to its nuclear properties, as well as the proven methods of obtaining it in required quantities and the results of its clinical use [ 1 , 7 , 8 , 9 , 10 ]. Two radiopharmaceuticals based on 177 Lu have been approved for use in clinical practice with marketing authorization: [ 177 Lu]Lu-DOTA-TATE (oxodotreotide, Lutathera ® [ 11 ]; RNT of neuroendocrine tumors) and [ 177 Lu]Lu-PSMA-617 (vipivotide tetraxetan, Pluvicto™ [ 12 ]; RNT of metastatic castrate-resistant prostate cancer). Research and development of new therapeutic radiopharmaceuticals with 177 Lu is actively ongoing.…”

Section: Introductionmentioning

confidence: 99%

Radiolysis-Associated Decrease in Radiochemical Purity of 177Lu-Radiopharmaceuticals and Comparison of the Effectiveness of Selected Quenchers against This Process

et al. 2023

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The radiolytic degradation of vector molecules is a major factor affecting the shelf life of therapeutic radiopharmaceuticals. The development of time-stable dosage forms of radiopharmaceuticals is the key to their successful implementation in clinical practice. Using [177Lu]Lu-PSMA-617 molecule as an example, the time dependence of the change in radiochemical purity (RCP, %) under radiolysis conditions was studied. The dependence of [177Lu]Lu-PSMA-617 radiolysis on parameters such as time, radionuclide activity, buffer agent concentration, precursor amount, and preparation volume was evaluated. It was shown that the absorbed dose was the dominant factor influencing the RCP. The RCP value is inversely proportional to the absorbed dose in the [177Lu]Lu-PSMA-617 preparation and has an exponential dependence. The lutetium-177 dose factor ψ (Gy·mL·MBq−1) and PSMA-617 concentration-dependent dose constant κ (Gy−1) were evaluated for absorbed dose estimation via computer modeling, chemical dosimetry, and radiochemical purity monitoring under various conditions. The further refinement and application of the dependencies found can be useful for predicting the RCP value at the stage of optimizing the composition of the finished dosage form of therapeutic radiopharmaceuticals. The influence of the buffer agent (sodium acetate) concentration on [177Lu]Lu-PSMA-617 radiolytic degradation was shown and should be considered both when developing a dosage form, and when comparing the results of independent studies. The effectiveness of the addition of various stabilizing agents, such as DMSA, cysteine, gentisic acid, vanillin, methionine, adenine, dobesilic acid, thymine, uracil, nicotinamide, meglumine, and mannitol, in suppressing the effects of radiolysis was evaluated.

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[177Lu]Lu-PSMA-617 (PluvictoTM): The First FDA-Approved Radiotherapeutical for Treatment of Prostate Cancer

Cited by 122 publications

References 44 publications

PET Criteria by Cancer Type from Imaging Interpretation to Treatment Response Assessment: Beyond FDG PET Score

PET Criteria by Cancer Type from Imaging Interpretation to Treatment Response Assessment: Beyond FDG PET Score

DNA Damage Repair Defects and Targeted Radionuclide Therapies for Prostate Cancer: Does Mutation Really Matter? A Systematic Review

Radiolysis-Associated Decrease in Radiochemical Purity of 177Lu-Radiopharmaceuticals and Comparison of the Effectiveness of Selected Quenchers against This Process

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