Comparison of Changes in Tumor Burden (Toral Tumor Volume [TMTV] and Total Lesion Activity [TLA]) in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in the Monitoring of Metastatic Castration-resistant Prostate Cancer Treated With 177Lutetium-PSMA-617

To demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.

Start Date01 Sep 2024

Sponsor / Collaborator

Centre Hospitalier Regional de Nancy

NCT06145633 / Not yet recruitingPhase 2IIT

Vorinostat to Augment Response to Lutetium-PSMA-617 in the Treatment of Patients With PSMA-Low Metastatic Castration-Resistant Prostate Cancer

This phase II trial tests how well vorinostat works in treating patients with prostate-specific membrane antigen (PSMA)-low castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) (mCRPC). Prostate cancer that has not spread to other parts of the body (localized) is typically treated through surgery or radiotherapy, which for many men is curable. Despite definitive local therapy, cancer that has come back after a period of improvement (recurrent) disease develops in 27-53% of men. Often this is detected by measurement of prostate-specific antigen (PSA) without visible evidence of metastatic disease. Lutetium Lu 177 vipivotide tetraxetan (177Lu-prostate specific membrane antigen [PSMA]-617) is a new small molecule PSMA-targeted radioactive therapy that has been approved by the Food and Drug Administration for the treatment of adult patients with PSMA-positive mCRPC who have been treated with androgen receptor inhibitors and taxane-based chemotherapy. Vorinostat is used to treat various types of cancer that does not get better, gets worse, or comes back during or after treatment with other drugs. Vorinostat is a drug which inhibits the enzyme histone deacetylase and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat and 177Lu-PSMA-617 may kill more tumor cells in in patients with PSMA-low mCRPC.

Start Date01 Aug 2024

Sponsor / Collaborator

University of Washington

[+2]

NCT06216249 / Not yet recruitingPhase 2

A Phase 2 Randomized Trial in Patients With Metastatic Castration Resistant Prostate Cancer to Determine the Efficacy of a Flexible Dosing Schedule of Lu-PSMA Treatment up to 12 Cycles Including Potential Treatment Holiday Periods in Comparison to the Standard Fixed Dosing Schedule of Six Cycles Every Six Weeks (FLEX-MRT)

The randomized phase 2 FLEX MRT compares a group of patients treated with LuPSMA on a flexible and extended dosing schedule including "treatment holiday" periods (investigational arm, up to 12 cycles) to a control group treated with a fixed dosing schedule of 6 treatments cycles maximum administered every 6 weeks.
The flexible dosing schedule in the investigational arm, will be based on SPECT/CT response assessments obtained 24h after injection of LuPSMA therapy cycle. The response assessment during treatment holiday period will be based on PET/CT every 12 weeks.

Start Date01 Jul 2024

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

100 Clinical Results associated with Lutetium (177 Lu) Vipivotide Tetraxetan

100 Translational Medicine associated with Lutetium (177 Lu) Vipivotide Tetraxetan

100 Patents (Medical) associated with Lutetium (177 Lu) Vipivotide Tetraxetan

345

Literatures (Medical) associated with Lutetium (177 Lu) Vipivotide Tetraxetan

01 Mar 2024·Biosensors & bioelectronics

Low cost, high temporal resolution optical fiber-based γ-photon sensor for real-time pre-clinical evaluation of cancer-targeting radiopharmaceuticals

Article

Author: Seo, Youngho ; Anwar, Mekhail ; Lee, Kyoungtae ; Evans, Michael ; Lall, Rahul ; Chopra, Shalini ; Niknejad, Ali ; Kandala, Averal

Cancer radiopharmaceutical therapies (RPTs) have demonstrated great promise in the treatment of neuroendocrine and prostate cancer, giving hope to late-stage metastatic cancer patients with currently very few treatment options. These therapies have sparked a large amount of interest in pre-clinical research due to their ability to target metastatic disease, with many research efforts focused towards developing and evaluating targeted RPTs for different cancer types in in vivo models. Here we describe a method for monitoring real-time in vivo binding kinetics for the pre-clinical evaluation of cancer RPTs. Recognizing the significant heterogeneity in biodistribution of RPTs among even genetically identical animal models, this approach offers long-term monitoring of the same in vivo organism without euthanasia in contrast to ex vivo tissue dosimetry, while providing high temporal resolution with a low-cost, easily assembled platform, that is not present in small-animal SPECT/CTs. The method utilizes the developed optical fiber-based γ-photon biosensor, characterized to have a wide linear dynamic range with Lutetium-177 (¹⁷⁷Lu) activity (0.5-500 μCi/mL), a common radioisotope used in cancer RPT. The probe's ability to track in vivo uptake relative to SPECT/CT and ex vivo dosimetry techniques was verified by administering ¹⁷⁷Lu-PSMA-617 to mouse models bearing human prostate cancer tumors (PC3-PIP, PC3-flu). With this method for monitoring RPT uptake, it is possible to evaluate changes in tissue uptake at temporal resolutions <1 min to determine RPT biodistribution in pre-clinical models and better understand dose relationships with tumor ablation, toxicity, and recurrence when attempting to move therapies towards clinical trial validation.

01 Feb 2024·Clinical nuclear medicine

Promising Therapeutic Activity of 177Lu-PSMA-617 in Synchronous High-Volume Metastatic Hormone-Sensitive Prostate Cancer

Article

Author: Ballal, Sanjana ; Satapathy, Swayamjeet ; Yadav, Madhav Prasad ; Sahoo, Ranjit Kumar ; Bal, Chandrasekhar

Purpose:

177Lu-PSMA-617 has been shown to improve survival outcomes in patients with end-stage metastatic castration-resistant prostate cancer. However, data in earlier lines remain limited. In this study, we intended to evaluate the efficacy and safety of 177Lu-PSMA-617 in patients with synchronous high-volume metastatic hormone-sensitive prostate cancer (mHSPC).

Patients and Methods:

Hormone-sensitive prostate cancer patients with synchronous high-volume metastases (defined as ≥4 skeletal metastases with ≥1 extra-axial site or any visceral metastasis) showing high PSMA expression on 68Ga-PSMA-11 PET/CT and ineligible/unwilling for conventional chemohormonal treatment options were selected. Approximately, ~5.55–7.4 GBq of 177Lu-PSMA-617 was administered intravenously at 8–12 weeks intervals, up to 6 cycles. All patients underwent concomitant androgen deprivation therapy/orchiectomy. The outcome measures included the proportion of patients achieving an undetectable serum prostate-specific antigen (PSA) (ie, ≤0.2 ng/mL) at any time point after therapy, best PSA response rate, objective radiographic response rate, radiographic progression-free survival, overall survival, and adverse events.

Results:

Ten patients with high-volume mHSPC received a median cumulative activity of 32.4 GBq (range, 7.4–44.4) of 177Lu-PSMA-617 over 1–6 cycles. Five patients (50%) achieved an undetectable PSA with 9 patients (90%) showing a ≥50% decline in PSA from baseline. Nine patients underwent radiological follow-up, of which 7 (77.8%) had an objective response. The median radiographic progression-free survival was 24 months (95% confidence interval, 18–30), whereas the median overall survival was not reached. None of the patients had any grade 3/4 adverse event.

Conclusions:

177Lu-PSMA-617 seems to be a promising efficacious and safe treatment option for patients with synchronous high-volume mHSPC.

01 Feb 2024·Clinical nuclear medicine

177Lu-PSMA-617 Therapy in a Case of Metastatic Castration-Resistant Prostate Cancer

Article

Author: Li, Hongmei ; Chen, Yue ; Qu, Gengcuo ; Zhang, Yu ; Hua, Qingchu

Abstract:

We report a 65-year-old man with metastatic castration-resistant prostate cancer who was treated with 2 cycles of 177Lu-PSMA-617 therapy. PET/CT imaging of 68Ga-PSMA-11 revealed a complete metabolic response (PERCIST1.0) after therapy. The prostate-specific antigen concentration drastically decreased (97.7% down).

245

News (Medical) associated with Lutetium (177 Lu) Vipivotide Tetraxetan

25 Jun 2024

·www.biospace.com

Radiopharmaceutical Industry Outlook: Growth Trends and Future Prospects

The concept of radiopharmaceuticals has been around for several decades. The field of radiotherapeutics has seen rapid development due to advances in radioisotope-based therapies, multimodality bioimaging technology, nanotherapeutics, and interventional oncology. The success of Novartis' prostate cancer drug Pluvicto further led to the resurgence of interest among prominent players in the field, leading to numerous clinical trials testing novel radiotheranostics. What are radiopharmaceuticals, and what are some statistics about the procedures performed globally? Radiopharmaceutical is a combination of radioactive isotopes and pharmaceutical drugs. They are used to diagnose and treat life-threatening diseases such as cancer, cardiac disorders, and neurological disorders. They are utilized in 3 procedures: SPECT imaging, PET imaging and therapeutics. Radiopharmaceuticals are transforming the treatment of various diseases, especially cancers, with targeted radionuclide therapy. Radioligand therapy targets cancer cells with high doses of radiation, promising advancements in cancer treatment. The widespread use of nuclear medicines is evident from a number of procedures performed globally. According to the World Nuclear Association, the annual number of nuclear medicine procedures performed exceeds 50 million, and the need for radioisotopes is rising. Radioisotopes are employed in the medical field by more than 10,000 hospitals worldwide, with approximately 90% of the procedures being diagnostic. Technetium-99 (Tc-99m) is the most often used radioisotope in nuclear medicine diagnostics; it is utilized in approximately 80% of nuclear medicine procedures and 85% of diagnostic scans performed globally. Additionally, in the US and Europe, 20 million and about 10 million nuclear medicine procedures are performed annually, respectively, with 2 million being therapeutic. SPECT is the current major scanning technology employed to diagnose and monitor a wide range of medical conditions; however, PET is expected to be preferred in future over SPECT as it is a more precise and sophisticated technique in the diagnosis of cancers and is well-used in cardiac and brain imaging. Tc-99m and 18F- FDG are the major radiopharmaceuticals for SPECT and PET imaging, which account for 80% of all nuclear medicine procedures. However, the availability of new radiopharmaceuticals, such as PET imaging agents flutemetamol and florbetapir used in neurological conditions and cancer theranostic, drive molecular imaging in the clinical setting. Read our related market research report’s key insights: Radiopharmaceutical CDMO/CMO Services Market Key Insights 2024 Radiotheranostics Market Key Insights 2024 Radiopharmaceuticals Market Key Insights 2024 Radioligand Therapy Market Key Insights 2024 Radioactive Tracer Market Key Insights 2024 What are the different components of the radiopharmaceuticals market: Radioligand therapy, nuclear pharmacy, radiotheranostics, and radioactive tracers are various components used in radiopharmaceuticals to diagnose and treat diseases. The increasing utilization of these components drives substantial growth in the radiopharmaceutical industry. With rising demand for targeted cancer treatments, advanced diagnostic procedures, and integrated therapeutic solutions, these segments play pivotal roles in expanding the market. As technological innovations continue to enhance precision and efficiency, the radiopharmaceutical industry is poised for sustained growth and global expansion in the coming years. Radioligand Therapy/ Radiopharmaceutical Therapeutics Radioligand therapy (RLT) utilizes targeted medicines, often employing radioactive isotopes like lutetium-177, to bind to tumour targets, offering high rates of long-term tumour remission and stability, particularly for metastasized disease. Nuclear Pharmacy Nuclear pharmacy, a pharmacy subspecialty, focuses on preparing, dispensing, and managing radioactive materials used in nuclear medicine operations. Radiotheranostics Radiotheranostics uses radioactive probes to diagnose and treat specific cells, usually cancer cells. It's a combination of molecular imaging and targeted therapy that uses a ligand-linker-radioisotope design. Radioactive Tracer Radioactive tracers are diagnostic radiopharmaceuticals used to image the body and identify diseases. These are composed of tightly bonded molecules with a radioactive atom. So, what are the market dynamics of the Radiopharmaceutical industry? Key driving factors: Advancements in imaging technology Growth in PET imaging procedures driven by prostate, cardiac, and amyloid imaging due to better imaging, significantly lower false negatives and faster examination time Diagnostic and therapeutic application expansion of radiopharmaceuticals in new applications such as cardiology, neurology apart from oncology The ageing population and rising prevalence of target diseases increase the target population Availability of new products in PET and Theranostics segment Expansion of radioligand therapy into earlier lines of treatment (i.e., from 3L to include 2L, 1L and mHSPC populations) Innovative use of AI to enhance diagnostic accuracy and prognostics Rising demand for targeted cancer treatments Measures to close the gap between supply and demand for Mo-99 Market restraints: Stringent manufacturing and regulatory environment Requirement of robust raw material supply, manufacturing, and product transportation due to the short half-life of products Lack of skilled workforce Preconceived negative perceptions around the use of radioactive substances Trends - Investigation of new/ alternative radioisotopes such as 211 At, 223 Radium, and 212 Lead Supply chain advancements Integration with AI for diagnostic imaging Availability of radionuclide therapy programs in hospitals and cancer centers The radiopharmaceuticals sector is highly specialized, competitive and rapidly growing. Cardinal, GE, Novartis, Curium, and Jubilant are some of the prominent players in the industry. Major industry players are acquiring smaller companies with radiopharmaceuticals pipelines and investing in potential blockbuster products to get a foot in the door, which has resulted in significant investments, M&A, and funding. This can be attributed to the effectiveness of radiopharmaceuticals in cancer treatment and the commercial success of recently approved products such as Lutathera (Novartis) and Pluvicto (Novartis). In March 2024, AstraZeneca PLC completed the Canadian biotech Fusion Pharmaceuticals Inc. acquisition for $2 billion. In May 2024, Novartis AG acquired Mariana Oncology to enhance its research capabilities and clinical supply capacity in radioligand therapies. Similarly, in December 2023, Eli Lilly acquired POINT Biopharma Global Inc. with its lutetium-based portfolio for $ 1.4 billion. That same month, BMS purchased RayzeBio, Inc., including its Phase III actinium-based RYZ101, for $4.1 billion. Additionally, radiopharmaceuticals are being developed by significant drugmakers, a few publicly traded companies, and at least a dozen biotechnology startups. The under-development pipeline includes several PET & SPECT imaging agents, and targeted theranostic radiopharmaceuticals for diagnosing cancer and non-cancer indications. For instance, Clarity Pharmaceuticals, an innovative radiopharmaceutical with its Targeted Copper Theranostic (TCT) platform of products, has SARTATE, SAR-bisPSMA, and SAR-Bombesin, next generation, highly targeted theranostic radiopharmaceutical for cancer. GE Healthcare has two new radiopharmaceuticals in the pipeline, PET and SPECT imaging. Expanding the radiopharmaceutical pipeline presents a substantial opportunity for improved patient care with increased access to cutting-edge imaging, improved treatment options, greater personalized treatment, lower radiation exposure, and potential for future advancements. Radioligand therapy is currently used in a small number of cancers. It appears to be a promising treatment option, and its use is anticipated to increase over time to treat various cancer types. The radiopharmaceutical market growth will be further boosted by the use of radioligand therapy together with other therapies, raising patient and healthcare professional awareness of radioligand therapy, coordinating and collaborating specialities involved in providing cancer care (medical oncologists, nuclear medicine physicians, and others), planning hospital capacity—both human and physical—to deliver radioligand therapy safely and effectively, and developing efficient nuclear waste disposal protocols tailored to the various types of therapy.

AcquisitionPhase 3Radiation Therapy

11 Jun 2024

·www.prnewswire.com

Global Anti-Radiation Drugs Market to Register Incremental Growth at a CAGR of ~9% by 2030 | DelveInsight

The rise in demand for anti-radiation drugs is mainly driven by several factors. These include the growing occurrence of side effects linked to cancer screening methods, heightened risks of exposure to radiological or nuclear emergencies, and the increasing focus of nuclear-capable nations on safeguarding against radiation. These trends are expected to fuel the expansion of the anti-radiation drugs market from 2024 to 2030. LAS VEGAS, June 11, 2024 /PRNewswire/ -- DelveInsight's Anti-Radiation Drugs Market Insights report provides the current and forecast market analysis, individual leading anti-radiation drugs companies' market shares, challenges, anti-radiation drugs market drivers, barriers, trends, and key market anti-radiation drugs companies in the market. Key Takeaways from the Anti-Radiation Drugs Market Report As per DelveInsight estimates, North America is anticipated to dominate the global anti-radiation drugs market during the forecast period. In the compound type segment of the anti-radiation drugs market, the Potassium iodide sub-category had a significant revenue share in the year 2023. This can be ascribed to the various characteristics and advantages associated with potassium iodide. Notable anti-radiation drugs companies such as Novartis AG, Anbex Inc., Amgen Inc., Myelo Therapeutics, Arco Pharmaceuticals LLC, BTG International Inc., Cellphire Inc., Darnitsa, Enzychem Lifesciences Corporation, Humanetics Corporation, Mission Pharmacal Company, Chrysalis BioTherapeutics Inc., Pluri Inc., Partner Therapeutics, HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG., RxBio Inc., Coherus Biosciences, Onconova Therapeutics, Jubilant Life Sciences, Soligenix Inc., and several others, are currently operating in the anti-radiation drugs market. In September 2023, the U.S. Department of Defense awarded Edina-based Humanetics a USD 20 million contract to develop a pill that prevents radiation damage in military members and first responders affected by events such as nuclear accidents, warfare, and dirty bombs. In May 2023, the first-in-human clinical trial of an experimental oral drug for removing radioactive contaminants from inside the body, testing the safety, tolerability, and processing in the body of escalating doses of the investigational drug product HOPO 14-1 was initiated in healthy adults. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, was funding the Phase 1 trial, which was sponsored and conducted by SRI International of Menlo Park, California. In March 2022, Novartis announced that the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) that has spread to other parts of the body. These patients have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy). To read more about the latest highlights related to the anti-radiation drugs market, get a snapshot of the key highlights entailed in the Global Anti-Radiation Drugs Market Report Anti-Radiation Drugs Overview Anti-radiation drugs are pharmaceutical compounds designed to mitigate the damaging effects of radiation exposure on the human body. These drugs work by either scavenging free radicals generated by radiation or by enhancing the repair mechanisms of cells damaged by radiation. One class of anti-radiation drugs includes radioprotectors, which are administered before radiation exposure to prevent or reduce its harmful effects. Another class, known as radiomitigators, is given after exposure to alleviate the severity of radiation-induced damage. These drugs hold significant promise in scenarios such as nuclear accidents, medical radiation therapy, and space travel, where the risk of radiation exposure is a concern. Research into anti-radiation drugs is ongoing, with scientists continually striving to improve their efficacy and minimize side effects. Some compounds under investigation show potential not only in protecting against acute radiation sickness but also in mitigating long-term effects such as cancer development. As our understanding of radiation biology advances, coupled with advancements in drug development technologies, the prospects for more effective and accessible anti-radiation drugs continue to brighten, offering hope for safer environments in radiation-prone situations. Anti-Radiation Drugs Market Insights In 2023, North America dominated the anti-radiation drugs market, primarily due to several factors contributing to growth. These include a substantial patient population afflicted with various illnesses like cancer, increasing numbers of diagnostic procedures, and governmental initiatives aimed at public health in the region. This trend is expected to continue from 2024 to 2030. The prevalence of cancer in the United States, for example, drives a significant demand for anti-radiation drugs. Statistics from the American Cancer Society projected around 2 million new cancer cases in the United States in 2024, leading to heightened demand for these drugs to support cancer diagnostic procedures. Additionally, the US benefits from a strong focus on clinical research and the presence of leading pharmaceutical companies, further bolstering the market for anti-radiation drugs. Moreover, in 2022, the US Department of Health and Human Services (HHS) allocated USD 290 million for the purchase of Nplate, a drug produced by Amgen USA Inc., intended to treat radiation sickness in the event of a nuclear emergency. This investment reflects ongoing efforts to enhance preparedness for radiological and nuclear emergencies and underscores the commitment to saving lives in such scenarios. To know more about why North America is leading the market growth in the anti-radiation drugs market, get a snapshot of the Anti-Radiation Drugs Market Outlook Anti-Radiation Drugs Market Dynamics The market dynamics of anti-radiation drugs are driven by a complex interplay of factors ranging from technological advancements to geopolitical events and regulatory frameworks. One of the primary drivers is the increasing threat of radiation exposure from various sources such as nuclear accidents, medical procedures, and potential radiological terrorism. This heightened awareness has propelled research and development efforts to create effective anti-radiation drugs that can mitigate the harmful effects of radiation exposure. Moreover, the growing prevalence of cancer and the widespread use of radiation therapy as a treatment modality has further fueled the demand for anti-radiation drugs. As more individuals undergo radiation-based treatments, there is a parallel need for medications that can protect healthy tissues and organs from the damaging effects of ionizing radiation. The competitive landscape of the anti-radiation drugs market is characterized by both established pharmaceutical companies and innovative startups vying for market share. Established players often leverage their resources and expertise to develop and commercialize new anti-radiation drugs, while startups focus on disruptive technologies and novel approaches to address unmet needs in radiation protection. Government initiatives and regulatory frameworks also play a crucial role in shaping the market dynamics of anti-radiation drugs. Regulatory agencies set standards for safety, efficacy, and quality assurance, which impact the development, approval, and commercialization of these medications. Additionally, government investments in research and development, as well as funding for procurement and stockpiling of anti-radiation drugs for emergency preparedness, influence market dynamics. Overall, the anti-radiation drugs market is characterized by a dynamic landscape driven by technological innovation, healthcare trends, regulatory factors, and geopolitical considerations. As the threat of radiation exposure continues to evolve, so too will the demand for effective anti-radiation drugs, driving further growth and innovation in this important sector of the pharmaceutical industry. Get a sneak peek at the anti-radiation drugs market dynamics @ Anti-Radiation Drugs Market Dynamics Analysis Anti-Radiation Drugs Market Assessment Anti-Radiation Drugs Market Segmentation Anti-Radiation Drugs Market Segmentation By Compound: Potassium Iodide, Prussian Blue, Diethylenetriamine Pentaacetic Acid, Colony Stimulating Factors, and Others Anti-Radiation Drugs Market Segmentation By Indication: Acute Radiation Syndrome, Cancer Treatment, and Others Anti-Radiation Drugs Market Segmentation By Radiation Type: Ionizing Radiations and Non-Ionizing Radiations Anti-Radiation Drugs Market Segmentation By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, and Others Anti-Radiation Drugs Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the anti-radiation drugs market are set to emerge as the trendsetter explore @ Anti-Radiation Drugs Companies Table of Contents Interested in knowing the anti-radiation drugs market by 2030? 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Radiation Therapy

06 Jun 2024

·www.fiercepharma.com

France's Orano Med debuts radiotherapy manufacturing plant near Indianapolis

The Indianapolis buildout follows Orano Med’s decision to start work on a similar facility in Valenciennes, France, to serve the European market. Amid a nuclear medicine boom, France’s Orano Med has chosen the U.S. to establish a manufacturing plant as it progresses on its radiopharma journey. Orano Med—which is working on targeted alpha therapies for cancer—on Thursday inaugurated its first Alpha Therapy Laboratory (ATLab) in Brownsburg near Indianapolis, Indiana. The site marks the world’s first industrial-scale facility dedicated to production of lead-212-based radioligand therapies, according to the company. Radiopharmaceuticals are guided radioactive drugs that can help diagnose diseases in smaller amounts and can treat cancers and other conditions in higher quantities. Unlike current approved beta-emitting-isotope-based radiotherapies like Novartis’ Pluvicto and Lutathera, Orano Med’s approach leverages the alpha-emitting isotope lead-212. Traditionally, radiotherapies have utilized beta particles because beta emitters were more easily available, Julien Dodet, CEO and president of Orano Med, said via email. That said, the Orano CEO figures using alpha particles can help boost the effectiveness of drug prospects. Orano Med has invested $20 million into ATLab Indianapolis, which it says will cover 30,000 square feet of floor space and create 25 new jobs within the company. The Indianapolis buildout follows Orano Med’s decision to start work on a similar facility in Valenciennes, France, to serve the European market. Together, the facilities are expected to allow Orano Med to crank out 10,000 radiopharma doses per year across the globe by 2025. The company aims to be able to produce 100,000 doses by 2030, according to its press release. Orano Med—a subsidiary of the nuclear materials leader Orano—is a clinical-stage biotech working to developing lead-212-based radiotherapies against cancer. Orano Med CEO Dodet noted that it’s important for radioligand therapy developers to hash out manufacturing and supply early given that radiotherapies must be produced “just-in-time” to be delivered to patients, thanks to the short half-life of isotopes. Despite the growing demand for radiopharmaceuticals—and especially for alpha emitters—existing manufacturing facilities are aging, with many relying on radioisotopes derived from Cold War-era sources or purchased from the U.S. Department of Energy, “which cannot keep up with demand," the CEO added. Radiopharmaceuticals have recently garnered significant interest among oncology-focused companies, with Novartis continuing to lead the charge. While Novartis already markets two FDA-approved radiotherapies, the company showed its continued interest in the field with its recent purchase of Mariana Oncology for up to $1.75 billion. As for its approved radiotherapies, Pluvicto and Lutathera generated a combined $1.6 billion last year. Manufacturers and suppliers have been getting in on the action too, such as CDMO Nucleus RadioPharma, which recently inked its first commercial contract to help manufacture ARTBIO’s Pb212-radiolabeled therapies from its facility in Rochester, Minnesota.

Acquisition

100 Deals associated with Lutetium (177 Lu) Vipivotide Tetraxetan

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	KR	Novartis AG	29 May 2024
PSMA-Positive Castration-Resistant Prostatic Cancer	EU	Novartis Europharm Ltd.	09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer	IS	Novartis Europharm Ltd.	09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer	LI	Novartis Europharm Ltd.	09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer	NO	Novartis Europharm Ltd.	09 Dec 2022
Castration-Resistant Prostatic Cancer	US	Novartis Pharmaceuticals Corp.	23 Mar 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Oligometastatic Prostate Carcinoma	Phase 3	US	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	JP	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	AU	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	CA	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	IL	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	SG	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	CH	Novartis Pharmaceuticals Corp.	12 Mar 2024
PSMA-Positive Prostatic Cancer	Phase 3	US	Novartis Pharmaceuticals Corp.	12 Mar 2024
PSMA-Positive Prostatic Cancer	Phase 3	JP	Novartis Pharmaceuticals Corp.	12 Mar 2024
PSMA-Positive Prostatic Cancer	Phase 3	AU	Novartis Pharmaceuticals Corp.	12 Mar 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04689828 (PSMAfore, ASCO2024) Manual	Phase 3	Metastatic castration-resistant prostate cancer AR \| TP53 \| PTEN	468	177Lu-PSMA-617 (ctDNA fraction >1%)	dmuqjxcatd(eavbderfpz) = xypzbilxwi lemmjvpmnh (dtnasvptmz, 5.8–11.3) View more	Positive	24 May 2024
				177Lu-PSMA-617 (ctDNA fraction ≤1%)	dmuqjxcatd(eavbderfpz) = oaeywbuntu lemmjvpmnh (dtnasvptmz, 11.5–NE) View more
177Lu-PSMA-617 (ASCO2024)	Not Applicable	PSMA-bTTV	138	177Lu-PSMA-617 treatment	lrrcyrsifm(hcowcmmese) = 8 (5.8%) patients had grade 3 anemia fmjtqzgdff (ugpkogovqn ) View more	Negative	24 May 2024
				177lu-PSMA-617
NCT03392428 (TheraP ANZUP 1603, ASCO2024)	Phase 2	Metastatic castration-resistant prostate cancer ctDNA	180	[177Lu]Lu-PSMA-617 (LuPSMA)	lybkkoyltq(hmapbbuhmm) = oqnwfzplmb udxwlomejo (wwmkyoajqn )	Positive	24 May 2024
				Cabazitaxel	lybkkoyltq(hmapbbuhmm) = vgvukjgafb udxwlomejo (wwmkyoajqn )
NCT06216249 (FLEX-MRT, ASCO2024)	Phase 2	PSMA positron emission tomography (PET)	90	Flexible dosing schedule of 177Lu-PSMA-617 RLT up to 12 cycles	xrxjvibeuk(gquvtzxpiy) = abhsfqikag lecjsltlhe (kgqqszjloq )	Positive	24 May 2024
				Fixed dosing schedule of 177Lu-PSMA-617 RLT 6 cycles	xrxjvibeuk(gquvtzxpiy) = zqptizuehl lecjsltlhe (kgqqszjloq )
ASCO2024	Not Applicable	Metastatic castration-resistant prostate cancer	-	177Lu-PSMA-617	utytpnazcz(ipituxzsrv) = vqkolbtihc dqhxxsejmw (njxsoqdjut, 45% - 66%) View more	-	24 May 2024
				177Lu-PSMA-617	utytpnazcz(ipituxzsrv) = tpjdqduvre dqhxxsejmw (njxsoqdjut, 23% - 59%) View more
ASCO2024	Not Applicable	PSMA-Positive Tumor	-	177Lu-PSMA plus protocol permitted standard of care (SOC)	iqcwaxvtrj(xxcfsedygv) = ebxwtiisbp dsytrwnjgf (dpydgfxyug )	-	24 May 2024
TheraP trial (ASCO2024)	Not Applicable	Metastatic castration-resistant prostate cancer PSMA \| FDG avid disease	32	Lutetium-PSMA-617	nfpjskrneq(mmowzlzpip) = ngbziczsds ygofsyiaru (jozzjhpesz ) View more	Positive	24 May 2024
PROMISE (ASCO2024)	Not Applicable	PSMA-Positive Castration-Resistant Prostatic Cancer PSMA PET+ \| DDR alterations \| tumor suppressor gene alterations (TSGa) (PTEN,p53,RB1) ... View more	115	PSMA PET+ mCRPC patients treated with 177Lu-PSMA-617	duoaedvzpt(omjoqktdry) = crnryqqorp uksnmofnuh (xjrjutrmss ) View more	Positive	24 May 2024
ASCO2024	Not Applicable	Metastatic castration-resistant prostate cancer	-	[177Lu]Lu-PSMA-617	xrfuabwyir(gboiepocwj) = xnrnnjqbmd mhfcjozuzm (mjxgijdpzd ) View more	-	24 May 2024
NCT04689828 (PSMAfore, AUA2024) Manual	Phase 3	Metastatic castration-resistant prostate cancer	-	177Lu-PSMA-617	nocsaodttx(sghxpsywer) = aswlmzefwq myfbpcvtvn (mlwogyoqao, 9.30-14.42) Met View more	Positive	03 May 2024
				ARPI change	nocsaodttx(sghxpsywer) = nnwbspmdkd myfbpcvtvn (mlwogyoqao, 4.17-5.95) Met View more

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