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.
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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
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urologytimes.com
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Agreement reached for public reimbursement of Pluvicto in Canada

Novartis secured public reimbursement of lutetium-177 vipivotide tetraxetan (Pluvicto) for PSMA-positive mCRPC patients in Canada. Pluvicto, approved by Health Canada in 2022 and the US FDA in 2022, offers hope for patients with advanced prostate cancer. The therapy still needs to be added to provincial formularies for patient access.
hitconsultant.net
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Nucs AI Secures $3.5M to Advance AI-Powered Prostate Cancer Diagnostics

Nucs AI, using AI in precision medicine for prostate cancer, closed a $3.5M seed round to build its platform and seek FDA clearance. Their tools, DeepPSMA and SelectPSMA, enhance PSMA-PET/CT imaging and predict patient response to PSMA-targeted radiopharmaceuticals, aiming to improve prostate cancer care.
nature.com
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A real-world pharmacovigilance study of FDA adverse event reporting system events for ...

First study to report AEs associated with 177Lu-PSMA-617 using FAERS database, identifying 6266 reports. Death (60.82%) most frequent severe outcome. Significant signals align with VISION trial, emphasizing hematological AEs. Renal toxicity not directly reflected. AEs prone to occur shortly after administration, with majority being grades 1–2. Study limitations include FAERS voluntary reporting and potential bias.
medpagetoday.com
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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.
mskcc.org
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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
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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.
urologytimes.com
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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.
eurekalert.org
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Nicole M. Maughan, PhD, receives SNMMI Mars Shot Fund Award

Nicole M. Maughan, PhD, receives $100,000 SNMMI Mars Shot Fund award for establishing a centralized dosimetry process with peripheral SPECT/CT image acquisition in radiopharmaceutical therapy, aiming to improve personalized treatment in community practices.
urologytimes.com
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UpFrontPSMA: 177Lu-PSMA-617 shows potential in mHSPC

177Lu-PSMA-617 plus docetaxel improved outcomes in metastatic hormone-sensitive prostate cancer (mHSPC) without increased toxicity compared to docetaxel alone, according to the phase 2 UpFrontPSMA study. The addition of lutetium-PSMA to docetaxel significantly improved undetectable PSA levels at 48 weeks and multiple secondary endpoints with no increase in overall toxicity.
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