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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
medpagetoday.com
·

Radioligand Shows Promise in Metastatic Hormone-Sensitive Prostate Cancer

In metastatic hormone-sensitive prostate cancer (mHSPC), adding 177Lu-PSMA-617 to androgen deprivation therapy (ADT) and chemotherapy doubled biochemical recurrence-free survival (BRFS) in the UpFrontPSMA trial. BRFS at 48 weeks increased from 16% to 41%. The median duration of freedom from castration resistance was 20 months with 177Lu-PSMA-617 versus 16 months without it. Adverse events did not increase significantly with the three-drug combination.

Related Clinical Trials:

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC
mskcc.org
·

MSK Research Highlights, October 15, 2024

MSK research identifies p53 gene mutation linked to breast cancer drug resistance, suggests CDK2/CDK4/6 inhibitor combo; phase 3 trial shows improved prostate cancer control with 177Lu-PSMA-617; MSK-led study finds optimal radiation dose for spinal metastasis to prevent complications; proton therapy proves effective against recurrent head and neck cancers.
targetedonc.com
·

GU Oncologists Anticipate Earlier Role of Lutetium-177 PSMA-617 in Prostate Cancer

FDA approval of lutetium-177 (177Lu) vipivotide tetraxetan (177Lu PSMA-617; Pluvicto) for metastatic castration-resistant prostate cancer (mCRPC) has led to its widespread use, with ongoing research exploring its potential in earlier disease stages. Oncologists are adapting to its regular use, focusing on patient selection via PSMA-PET scans. Early therapy with 177Lu-PSMA-617 has shown benefits in radiographical progression-free survival (rPFS) and quality of life (QOL), with ongoing trials aiming to expand its indications and improve patient outcomes.

Related Clinical Trials:

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment
A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer
Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
targetedonc.com
·

Detecting PSMA in Prostate Cancer Noninvasively With Liquid Biopsy

A novel epigenetic liquid biopsy platform could replace PSMA PET scans for detecting tumor PSMA expression in prostate cancer patients, offering a noninvasive, accessible method for precision treatment.
prnewswire.com
·

Australian TGA Approves Additional Indication for Telix's Illuccix® to Include Patient

Telix Pharmaceuticals announces TGA approval of Illuccix for selecting patients with metastatic prostate cancer for PSMA-targeted radionuclide therapy, expanding its clinical utility in Australia.

Related Clinical Trials:

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
urologytimes.com
·

Health Canada approves expanded indication of TLX591-CDx in prostate cancer

Health Canada approves Illuccix for selecting mCRPC patients for PSMA-targeted radionuclide therapy with 177Lu-PSMA-617. Illuccix, initially approved in Canada in 2022 and the US in 2021, aids in staging and re-staging prostate cancer and localizing tumor tissue. The VISION trial data supported FDA approval of 177Lu-PSMA-617 in 2022, showing improved PFS and OS in PSMA-positive mCRPC patients.

Related Clinical Trials:

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
onclive.com
·

Health Canada Expands Indication for Illuccix Diagnostic Kit for PSMA-Targeted

Health Canada expands Illuccix label for PSMA-11 PET imaging in mCRPC patients eligible for lutetium Lu 177 vipivotide tetraxetan therapy, enhancing access to advanced prostate cancer imaging.

Related Clinical Trials:

Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
biospace.com
·

Health Canada Approves Label Expansion for Telix's Illuccix® to Include Patient Selection

Health Canada approves Illuccix for selecting patients with progressive metastatic castration-resistant prostate cancer (mCRPC) for PSMA-targeted radionuclide therapy, expanding its clinical utility in Canada.

Related Clinical Trials:

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
urotoday.com
·

Novel Epigenomic Liquid Biopsy Detects PSMA Expression in Prostate Cancer

Dr. Jake Berchuck discusses a novel epigenomic liquid biopsy platform for determining PSMA expression in prostate cancer, showing strong correlation with PSMA PET scan results. The platform analyzes cell-free DNA to infer tumor PSMA expression, potentially guiding treatment decisions for cell surface-targeting therapies and offering genome-wide insights into gene regulation.
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