Phase lutetium. Medical search. Frequent questions

Phase IIb candidate combines Lutetium-177 radioisotope with PSMA-targeting antibody. (genengnews.com)
BZL Biologics and Atlab Pharma signed a sublicense agreement centered on global development of a radiolabeled monoclonal antibody cancer therapy combining Atlab's 177 Lutetium radioisotope with BZL's prostate-specific membrane antigen (PSMA)-targeting antibody J591. (genengnews.com)
The open-label phase 3 VISION trial (NCT03511664) accrued patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who received at least 1 novel androgen axis drug (eg, enzalutamide [Xtandi] or abiraterone acetate [Zytiga]) and were previously treated with 1 to 2 taxane regimens. (urologytimes.com)
Results showed that the trial of lutetium Lu-177 vipivotide tetraxetan met its primary endpoint, with a clinically meaningful and statistically significant benefit in radiographic progression-free survival in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer after previous treatment with androgen receptor pathway inhibitor(ARPI) therapy, compared to a change in ARPI (abiraterone or enzalutamide). (ascopost.com)
PSMAfore (ClinicalTrials.gov identifier NCT04689828 ) is a phase III, open-label, multicenter, 1:1 randomized study comparing the efficacy and safety of Lu-177 vipivotide tetraxetan to a change in ARPI (abiraterone or enzalutamide) in patients with PSMA-positive metastatic castration-resistant prostate cancer who have not been exposed to a taxane-containing regimen. (ascopost.com)
PSMA I&T was synthesized in a combined solid phase and solution chemistry strategy. (snmjournals.org)
PSMA I&T and its cold gallium and lutetium analog revealed nanomolar affinity toward PSMA. (snmjournals.org)
VIOLET is a phase I/II trial that will test a new PSMA-targeted radionuclide therapy, 161-Terbium-PSMA-I&T, in patients with progressive mCRPC. (pcf.org)
This treatment is similar in concept to the recently approved radionuclide therapy 177-Lutetium-PSMA-617 (Pluvicto®), but uses 161-Terbium instead of 177-Lutetium as the radioactive-emitting isotope. (pcf.org)
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Pluvicto ® (lutetium [ 177 Lu] vipivotide tetraxetan), 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 or who are not medically suitable for taxanes. (europeanpharmaceuticalreview.com)
The approval of Advanced Accelerator Applications (AAA)'s Pluvicto is based on the alternate primary endpoint results from the randomised, open-label, international, multi-centre, Phase III VISION trial, where patients with progressive PSMA positive mCRPC treated with at least one AR pathway inhibitor and one or two taxane regimens. (europeanpharmaceuticalreview.com)
Lutetium-177 (Lu-177) Prostate Specific Membrane Antigen (PSMA) therapy is a theranostics procedure used to treat prostate cancer. (qldxray.com.au)
At Queensland X-Ray, Lutetium PSMA therapy is delivered by a nuclear medicine specialist, with assistance from a highly skilled team of nuclear medicine technologists, nurses and clerical staff. (qldxray.com.au)
The PROQURE-I study is a multicenter prospective phase I study investigating standard of care treatment (7 weeks EBRT and 3 years ADT) complemented with one concurrent cycle (three, six, or nine GBq) of systemic [ 177 Lu]Lu-PSMA-617 administered in week two of EBRT. (biomedcentral.com)
New nomograms can predict survival outcomes for patients with metastatic castration-resistant prostate cancer (mCRPC) treated with lutetium-177 prostate-specific membrane antigen ( 177- Lu-PSMA), according to a study published in The Lancet Oncology . (renalandurologynews.com)
Dr. Shore reviews the phase 3 VISION trial which led to the approval of Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer. (urotoday.review)
conducted a phase 3 trial that evaluated lutetium-177 ( 177 Lu)-PSMA-617 plus protocol-permitted standard care as compared with standard care alone (control group) in a specific population of previously treated patients with metastatic castration-resistant prostate cancer who were selected for PSMA positivity on the basis of PSMA positron-emission tomographic imaging. (nejm.org)
New phase III 177 Lu-PSMA-617 trial in mCRPC patients who have not undergone chemotherapy. (minute-medical.com)
TLX591 is an rADC, constructed from a highly specific PSMA-targeting antibody, a chelator linker, and a lethal dose of lutetium. (patsnap.com)
ProstACT GLOBAL signifies the initial Phase III trial investigating TLX591 in PSMA-positive metastatic castrate-resistant prostate cancer adult patients, with administration along standard of care (SoC) contrasting standalone SoC. (patsnap.com)
We aimed to determine whether a single dose of lutetium-177 [177Lu]-prostate-specific membrane antigen (PSMA)-617 (177Lu-PSMA-617) followed by maintenance pembrolizumab was safe and could induce durable clinical benefit. (bvsalud.org)
At this year's EANM, Irene Marini presented preliminary results of IRST-185.03, an open-label, single-center, phase 2, prospective study (NCT03454750) evaluating the efficacy and toxicity of low-dose -radiometabolic therapy with 177 Lu-PSMA-617 in advanced mCRPC. (memoinoncology.com)
At ASCO 2021, Novartis presented positive results from the Phase III VISION trial of its lutetium-177-labeled PSMA-617 (prostate-specific membrane antigen) radiopharmaceutical, AAA-617, in progressive PSMA-positive, metastatic, castration-resistant prostate cancer. (bionest.com)
Novartis's PSMA-targeted radioligand has improved overall survival and progression-free survival in top-line results from the Phase III VISION study in prostate cancer, cementing the company's pioneering role in the therapeutic area. (citeline.com)
Basel, December 5, 2022 - Today, Novartis announced the pivotal Phase III PSMAfore study with Pluvicto TM (INN: lutetium ( 177 Lu) vipivotide tetraxetan), a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, met its primary endpoint. (swisslifesciences.com)
This is the second positive read-out for Pluvicto in a Phase III trial following the VISION study, where patients with PSMA-positive mCRPC who received Pluvicto plus standard of care after being treated with ARPI and taxane-based chemotherapy had a statistically significant reduction in risk of death 1,3 . (swisslifesciences.com)
With the announcement of these positive topline Phase III results, Pluvicto becomes the first PSMA-targeted radioligand therapy to demonstrate significant and clinically meaningful benefits for people living with this type of prostate cancer who have not received taxane-based chemotherapy," said Shreeram Aradhye, M.D., President, Global Drug Development and Chief Medical Officer, Novartis. (swisslifesciences.com)
PSMAfore is a Phase III, open-label, multi-center, 1:1 randomized study comparing the efficacy and safety of Pluvicto to a change in ARPI in patients with PSMA-positive mCRPC 13 . (swisslifesciences.com)

Peptide Receptor Radionuclide Therapy (PRRT) using Lutetium 177 (Lu-177) dotatate treats neuroendocrine tumors (NETs) by converting a cancer cell's unique characteristics into a welcome mat for a "Trojan Horse" packed with cancer-killing radiation. (netrf.org)
A preclinical evaluation of carbonic anhydrase IX- (CAIX)-targeted lutetium-177 radionuclide therapy in combination with immune checkpoint inhibition. (vietnamnews.net)

We look forward to a future where [lutetium Lu-177 vipivotide tetraxetan] may be a viable therapy for patients in need of alternative, earlier options. (ascopost.com)
The incidence of adverse events, including those of grade 3 or higher, during treatment was higher in the lutetium ( 177 Lu) vipivotide tetraxetan plus SOC group than in the SOC only group11. (europeanpharmaceuticalreview.com)
The most common treatment-emergent adverse events in those receiving lutetium ( 177 Lu) vipivotide tetraxetan plus SOC (all grades) were fatigue (43.1 percent), dry mouth (38.8 percent), nausea (35.3 percent), anaemia (31.8 percent), decreased appetite (21.2 percent) and constipation (20.2 percent). (europeanpharmaceuticalreview.com)
Following the granting of this marketing authorisation by the MHRA, Novartis, which owns AAA, will continue to work with the UK's National Institute for Health and Care Excellence (NICE) and National Health Service (NHS) to enable eligible patients in Great Britain to access lutetium ( 177 Lu) vipivotide tetraxetan. (europeanpharmaceuticalreview.com)
Pluvicto ® ▼ (lutetium ( 177 Lu) vipivotide tetraxetan) is subject to additional monitoring. (europeanpharmaceuticalreview.com)

These are combined with indium-111, lutetium-177 or yttrium-90 for treatment. (wikipedia.org)
Two radiopeptides are commonly used in PRRT: yttrium 90 (90Y) and lutetium 177 (Lu 177). (netrf.org)
I-131 and certain other clinically used radioisotopes (notably lutetium-177, samarium-153, and yttrium-90) are emitters of beta particle radiation. (bionest.com)

Pluvicto is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177) 3 . (swisslifesciences.com)

One commercial application has been as a pure beta emitter, using lutetium which has been exposed to neutron activation. (ssnano.com)
Lutetium-177 is a beta-emitter with a half-life of 6.7 days and a maximum energy of 0.5 MeV, corresponding to a maximum soft-tissue penetration of approximately 1 mm. (ymabs.com)

177 Lu-J591 is currently undergoing a Phase IIb trial in men with castration-resistant prostate cancer (MCRPC) who demonstrate rising prostate-specific antigen levels, but no detectable metastases. (genengnews.com)
This radioligand therapy has been associated with encouraging biochemical and radiographic response rates, reduced pain, and low toxicity in multiple early-phase studies involving patients with progression of metastatic castration-resistant prostate cancer after standard therapy. (nejm.org)
At the upcoming 2022 SNMMI Mid-Winter & ACNM Annual Meeting on February 25-27, 2022, data from the 27-patient safety and dosimetry lead-in cohort for the Company's Phase 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) will be presented. (businessclase.com)

Results of the NETTER-1 study , a large phase III randomized clinical trial published earlier this year, showed lutetium Lu 177 dotatate improved progression-free survival a median of 33 months when compared to high-dose OctreotideLAR in patients with advanced midgut NETs. (netrf.org)

The randomized controlled phase III Neuroendocrine Tumors Therapy (NETTER-1) trial evaluated the efficacy and safety of 177Lu-DOTATATE as compared with high-dose octreotide long-acting repeatable (LAR) in patients with advanced progressive somatostatin-receptor positive midgut neuroendocrine tumors. (wikipedia.org)
US Food and Drug Administration (FDA) approved lutetium Lu 177 dotatate for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. (netrf.org)
This follows a very positive year - in September, the Company received EU approval of Lutathera ® (lutetium-177 dotatate) for Gastroenteropancreatic Neuroendocrine tumours. (biospace.com)

Data from the phase III PSMAfore trial were presented during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2023 ( Abstract LBA13 ). (ascopost.com)
In March 2023 , RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, announced the completion of enrollment in the Phase 1b portion of the ACTION-1 Phase 1b/3 trial of RYZ101 in patients with SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who have progressed on Lutetium-177 labeled somatostatin analog therapy. (medgadget.com)
During EANM 2023, Neel Patel presented the design of the ongoing ProstACT GLOBAL multinational, multicenter, randomized, controlled, open-label phase 3 study (NCT04876651) [8]. (memoinoncology.com)
The Phase III data will be presented at an upcoming medical meeting and discussed with the US Food and Drug Administration (FDA) in 2023 for regulatory approval. (swisslifesciences.com)

The firm is focused on developing a pipeline of targeted anticancer drugs including antibodies, Lutetium-177-beta-emitting radiopharmaceuticals, and astatine-211 alpha-emitting radiopharmaceuticals. (genengnews.com)

Germany's Isotopen Technologien München (ITM) is also conducting Phase III studies with a lutetium-177 radiolabeled molecule that targets neuroendocrine receptors as a potential treatment for gastroenteropancreatic neuroendocrine tumors. (bionest.com)

177 Lu-omburtamab-DTPA embodies the Company's naked omburtamab antibody radiolabeled with lutetium-177, using DTPA to chelate the lutetium radioisotope to the antibody. (ymabs.com)
This chelator conjugated antibody can be linked to different radioisotopes for diagnostic ( 89 Zirconium) or therapeutic purposes ( 177 Lutetium, 111 Indium or 90 Yttrium) [5, 6]. (memoinoncology.com)

Researchers at Weill Cornell Medicine have led a phase 1 trial of a new drug that delivers potent radiation therapy directly and specifically to cancer cells in patients with advanced prostate cancer. (vighneshworld.com)

161-Terbium emits Auger electrons, depositing higher concentrations of radiation to micrometastases, and has shown superior preclinical results in comparison with 177-Lutetium. (pcf.org)
The report covers marketed products details and also drugs that are in various phases of development (Discovery, Preclinical & Clinical). (iq4i.com)

The grant will support the initiation and execution of Phase 1 clinical trial with TraceNETTM, a novel copper-based radio diagnostic for detecting neuroendocrine tumors (NET). (medgadget.com)

POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. (bigcountryhomepage.com)
We are dedicated to applying our technologies to improve the supply chain, including producing high-quality and high-volume medical isotopes and our plan to become the first vertically integrated supplier of lutetium-177. (shinefusion.com)
In its second phase, SHINE is creating critical medical isotopes used to diagnose and treat life-threatening diseases in patients across the globe. (shinefusion.com)

In a phase-0 study, the biokinetics of skeletal and non-skeletal uptake of 177Lu-EDTMP was assessed in 6 patients with metastatic prostate cancer using tracer doses (172.7-206.9MBq). (nih.gov)
For the phase-I study, 21 patients with metastatic prostate cancer were given a therapeutic dose of 177Lu- EDTMP (692-5550MBq). (nih.gov)
The candidate has successfully completed a Phase II trial in castrate-resistant metastatic prostate cancer patients. (genengnews.com)

Previously, scientists at Weill Cornell Medicine radiolabeled J591 with beta particle emitters, such as lutetium-177 (177Lu). (vighneshworld.com)

The development of Lutetium 177 DOTA rosopatamab represents a significant advancement in the field of biomedicine, particularly in the treatment of Prostatic Cancer. (patsnap.com)

In this multicenter phase 2 trial, the authors examined the safety and efficacy of adding the immune checkpoint inhibitor pembrolizumab to standard TMT in this patient population. (urologytimes.com)
We anticipate that an international multicenter Phase 1/2 clinical trial will be initiated for the screening of pediatric patients with medulloblastoma during the fourth quarter of 2020. (ymabs.com)

However, on a significant number of more recent periodic tables you will find lutetium and lawrencium classified as transition metals and placed directly underneath scandium and yttrium in group 3 of the periodic table. (rsc.org)

The primary endpoint in part A was determination of the recommended phase 2 schedule, and in part B, the objective response rate. (bvsalud.org)

Telix Pharmaceuticals Limited has declared that the initial participant has been given a dose in the firm's Phase III ProstACT GLOBAL trial. (patsnap.com)

We look forward to continuing to advance 225Ac-J591 in a combined phase 1/phase 2 follow-up study and future trials. (vighneshworld.com)
The Company expects these results to support their plans to commence Phase II trials in 2018. (biospace.com)
In multiple phase III clinical trials where a second AR-targeted agent was the control arm, if you will, the median time to progression was somewhere around 2.5 to 3.5 months. (medpagetoday.com)
Novartis is now studying AAA-617 in two Phase III trials for earlier stage metastatic prostate cancers, comparing the drug with other forms of radiation treatment as well as other cancer therapies. (bionest.com)
Interview: Germany's ITM is executing on its plan to develop targeted radionuclide-based therapies with its lead lutetium-177 product in Phase III trials supported by a just closed $109m financing. (citeline.com)

Results from the Phase III VISION study have shown the significance of this precision medicine for patients with advanced prostate cancer and it is encouraging to see such innovations being recognised by the MHRA with this licensing authorisation. (europeanpharmaceuticalreview.com)
Avalon Ventures Ltd. is pleased to announce the assay results from the remaining twelve holes from the Phase 2 winter drilling program on the Lake Zone Rare Earth Element ("REE") deposit. (miningtopnews.com)
Previously disclosed Phase II study results highlighted a 42.3-month overall survival rate and a satisfactory safety profile when provided under a fractionated dosing regimen in combination with docetaxel chemotherapy. (patsnap.com)

Today's announcement of marketing authorisation for lutetium treatment is another positive milestone for eligible patients and their families. (europeanpharmaceuticalreview.com)
SHINE is deploying and scaling fusion technology in a four-phased approach to solve today's problems in medicine, manufacturing and nuclear waste recycling, with the final goal of achieving safe, clean, abundant fusion energy. (shinefusion.com)

We also provide Lutetium Oxide powder with other purity and particle size upon request. (ssnano.com)

As the highest dose level of 225Ac-J591 that could be given without severe side effects was not reached and only one dose was administered in the phase 1 trial, a follow-up combined phase 1/phase 2 study is now underway. (vighneshworld.com)
METHODS: We did an open-label, dose-expansion, phase 1 study at the University of California, San Francisco (San Fransisco, CA, USA). (bvsalud.org)

SHINE is opening the largest facility in North America dedicated to the production of non-carrier-added lutetium-177, a medical isotope being used in targeted cancer therapies. (shinefusion.com)

The encouraging dosimetry and toxicity data of 177Lu-EDTMP reported provide the basis for subsequent phases of the studies to establish complete effectiveness and safety of 177Lu-EDTMP as an attractive alternative to other radioactive bone pain palliation agents. (nih.gov)

Recently, NETRF, in collaboration with the Educational Research Fund for Nuclear Medicine and Molecular Imaging, funded an early phase clinical research of PRRT . (netrf.org)

Rosapatamab has further been evaluated in combination with standard-of-care docetaxel in a phase 1 study including 15 patients with progressive mCRPC and showed preliminary encouraging efficacy [7]. (memoinoncology.com)

With the need for more treatment options, Dr. Tagawa conducted the phase 1 study of 225Ac-J591 between October 2017 and January 2021 at Weill Cornell Medicine and Tulane University School of Medicine. (vighneshworld.com)
On September 29, 2017, the European Commission approved the marketing of lutetium (177Lu) oxodotreotide for midgut NETs in all 28 European Union member states, as well as Iceland, Norway, and Liechtenstein. (netrf.org)

In previous phase 1 and 2 studies, 177Lu-J591 effectively targeted metastatic sites with acceptable toxicity and showed encouraging signs of response and improvements in overall survival. (vighneshworld.com)

Hi, I'm so excited to be at AUA 2022, where I have the opportunity to speak with Dr. Neal Shore about the integration of Lutetium into our clinical practices, from a urologist perspective. (urotoday.review)
I think that all of our colleagues who treat prostate cancer regardless of your specialty, are going to be having a really full throated conversation in 2022, and with the approval of Lutetium 617, but then others that are going to be coming along. (urotoday.review)
POINT's Indianapolis manufacturing facility opened in October 2021, the Investigational New Drug (IND) amendment to add the facility to the Company's supply chain for the SPLASH trial occurred in December 2021, and production of no-carrier-added (n.c.a.) lutetium-177 (Lu-177) PNT2002 clinical trial product commenced in January 2022. (businessclase.com)

But this fact has not convinced everyone and nor have the numerous chemical and physical similarities that exist when lutetium and lawrencium are considered as homologues of scandium and yttrium. (rsc.org)

Herein, we report the pharmacokinetics, dosimetry and toxicity analysis of 177Lu-EDTMP in patients (phase-0/I study). (nih.gov)
In October, Enterome , a pioneer in the development of pharmaceuticals and diagnostics based on the gut microbiome, successfully completed a Phase I clinical study of its lead candidate EB8018, a potential new orally administered treatment for Crohn's disease. (biospace.com)
So far, a total of 242 patients have received treatment throughout eight Phase I and II studies on TLX591, including Telix's ProstACT SELECT study which authenticated the clinical efficacy of Telix's ideal fractionated dosage and safety trait of the product. (patsnap.com)

"Lutetium-177 (Lu-177) Global Market and Pipeline Analysis - Forecast to 2028" gives comprehensive insights on the various Lu-177 based drugs being developed for the treatment of developed for the treatment of prostate cancer, NETs, Lung cancer, solid tumors and other conditions. (iq4i.com)
Alnylam reports encouraging findings from the KARDIA-1 Phase 2 trial of Zilebesiran, a potential RNAi treatment, designed for addressing hypertension in individuals with significant cardiovascular risk. (patsnap.com)

Studies of its aqueous phase also show that it displays trivalency. (rsc.org)
So far, 177 Lu-HuJ591 has been tested in more than 100 patients in four phase 1 and 2 studies with single as well as repeated and fractionated doses [5]. (memoinoncology.com)

The parallel assignment, double-blind phase 3 KEYNOTE-564 trial (NCT03142334) included patients with renal cell carcinoma (RCC) with a clear cell component who had undergone nephrectomy and had intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED). (urologytimes.com)
Dr. Frank A. Vicini, MD , FACR, FASTRO, FABS, who is a radiation oncologist with GenesisCare , discussed his findings from a phase III trial presented at ASTRO22 that evaluated new and improved techniques to treat patients with breast cancer. (itnonline.com)
In part B, 25 patients were enrolled using the recommended phase 2 schedule. (bvsalud.org)

Actinium is about four thousand times more potent and has a shorter delivery range than lutetium, delivering more energy to kill cancer cells with less harm to surrounding healthy tissue," Dr. Tagawa said. (vighneshworld.com)

The elements placed directly under scandium and yttrium in older periodic tables are lanthanum and actinium, but on the basis of electronic configurations lutetium and lawrencium have as much right to occupy these two places. (rsc.org)

We also provide Lutetium Metal with other specifications upon request. (ssnano.com)

Chemicals and Drugs3

Analytical, Diagnostic and Therapeutic Techniques and Equipment5

PSMA28

Radionuclide therapy2

Vipivotide tetraxetan5

Yttrium-903

Pluvicto1

Beta emitter2

Castration-resistant prostate cancer3

Progression free sur1

Dotatate3

20234

Radiopharmaceuticals1

Gastroenteropancreatic neuroendocrine1

Antibody2

Therapy1

Preclinical2

Neuroendocrine tumors1

Medical isotopes3

Metastatic prostate cancer3

Emitters1

Rosopatamab1

Multicenter2

Transition1

Primary endpoint1

ProstACT GLOBAL1

Trials5

Results3

Today's2

Particle1

Dose2

Therapies1

Radioactive1

Nuclear medicine1

MCRPC1

20172

J5911

20223

Chemical1

Study3

Treatment2

Studies2

Patients3

Cancer1

Basis1

Provide1