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Lutetium Lu-177 vipivotide tetraxetan

Generic Name
Lutetium Lu-177 vipivotide tetraxetan
Brand Names
Pluvicto
Drug Type
Small Molecule
Chemical Formula
C49H68LuN9O16
CAS Number
1703749-62-5
Unique Ingredient Identifier
G6UF363ECX
Background

Lutetium Lu-177 vipivotide tetraxetan is a radioligand therapeutic agent. It consists of a radionuclide, lutetium Lu-177, linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer.

Lutetium Lu-177 vipivotide tetraxetan was first approved by the FDA on March 23, 2022 as a treatment for prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended lutetium Lu-177 vipivotide tetraxetan be granted marketing authorization for the treatment of prostate cancer. In December 2022, lutetium Lu-177 vipivotide tetraxetan was approved by the EMA.

Indication

Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.

Associated Conditions
Metastatic Castration-Resistant Prostate Cancer (mCRPC), Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Associated Therapies
-
Clinical Trials
Related News
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Eli Lilly brings the competition to Novartis with new results in mCRPC

Eli Lilly’s 177Lu-PNT2002, compared to ARPIs like Xtandi and Zytiga, showed efficacy in mCRPC patients positive for PSMA at ESMO 2024. Despite initial negative OS results, crossover adjustments led to a favorable HR of 0.68, likely influencing FDA approval. 177Lu-PNT2002, with lower dosage and fewer cycles than Pluvicto, may challenge Novartis’s market position.
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Novartis Pluvicto™ shows clinically meaningful and highly significant improvement in Phase III PSMAfore trial

The Phase III PSMAfore trial demonstrated Pluvicto™ significantly improved radiographic progression-free survival (rPFS) in PSMA-positive mCRPC patients, doubling median rPFS to 12.0 months. Pluvicto also enhanced quality of life and showed favorable safety. OS data collection continues, with next analysis expected in 2024.

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177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
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pmc.ncbi.nlm.nih.gov
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Innovation in Radionuclide Therapy for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Radionuclide therapies, especially 177Lu-PSMA-617, show promise in treating metastatic castration-resistant prostate cancer (mCRPC), targeting prostate-specific membrane antigen (PSMA) for improved survival. Clinical trials highlight their efficacy and safety, with ongoing research exploring combination therapies and new radionuclides for enhanced treatment outcomes.

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Meeting Report from the Prostate Cancer Foundation

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Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
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