Phase I Trial of [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers

Background:
Some cancers have high levels of proteins called somatostatin receptors (SSTRs) on the surface of the tumors. These tumors can be in the lung, head and neck, digestive tract, kidneys, and in or near the adrenal glands. Researchers want to know if drug treatments that target SSTRs can help shrink these types of tumors.
Objective:
To test a study drug ([212Pb]VMT-Alpha-NET) in people with tumors that have SSTRs.
Eligibility:
People aged 18 years and older with tumors of the lung, kidneys, head and neck, digestive tract, or adrenal glands that have SSTRs. Their tumors must have spread to other organs and cannot be removed with surgery.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. A sample of tumor tissue may be collected if one is not already available.
[212Pb]VMT-Alpha-NET is given through a tube attached to a needle inserted into a vein. The drug will be given on the first day of four 8-week cycles. Participants will stay in the hospital for a few nights after each dose. They will have blood tests once a week during each cycle.
Some participants will also get a related study drug ([203Pb]VMT-Alpha-NET). They will receive this drug a few days before the first 2 cycles. At 4, 24, and 48 hours after each infusion, they will have whole body scans. These scans will show where the study drug went in their body.
Follow-up visits will continue up to 6 years after the last treatment.

开始日期2025-06-26

申办/合作机构

National Cancer Institute

NCT06427798

/ Recruiting临床1/2期IIT

Phase I/II Trial of Systemic Targeted Radioligand Therapy (TRT) With Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR Positive (SSTR+) Gastrointestinal (GI) Neuroendocrine Tumors (NET) and Pheochromocytoma/Paragangliomas Previously Treated With Systemic Radioligand Therapy

Background:
Gastrointestinal neuroendocrine tumors (GI NET) are a type of cancer that affects the stomach and intestines; pheochromocytoma/paragangliomas (PPGL) are tumors that grow in or near the adrenal glands. Both of these types of tumor have high levels of a protein called somatostatin receptors (SSTR) on their surfaces. Researchers want to test a treatment that targets SSTR.
Objective:
To test a drug ([212Pb]VMT-alpha-NET) in people with GI NET or PPGL. The drug has 2 components: a protein to bind to SSTR and a radioactive agent to kill the cancer cells.
Eligibility:
Adults aged 18 years or older with GI NET or PPGL tumors that have spread and cannot be removed with surgery.
Design:
Participants will be screened. They will have a physical exam, with imaging scans, blood tests, and tests of their heart function.
[212Pb]VMT-alpha-NET is given through a tube attached to a needle inserted into a vein (infusion). Treatment will be given in four 8 week cycles. Participants will receive the drug on the first day of each cycle. They will remain in the clinic at least 4 hours after each infusion and may need to stay in the hospital for up to 48 hour for monitoring and testing. They will have blood tests every week of each cycle.
Some participants will also get a related study drug ([203Pb]VMT-alpha-NET). They will receive this drug a few days before the first 2 cycles. At 4, 24, and 48 hours after each infusion, they will have whole body scans. These scans will show where the study drug went in their body.
Follow-up visits will continue for 10 years....

开始日期2025-02-07

申办/合作机构

National Cancer Institute

NCT06148636

/ Active, not recruiting早期临床1期IIT

A Phase 1, First-in-human Clinical Trial of [212Pb] VMT-alpha-NET Using a Forward Dosimetric Planning Technique to Treat Refractory or Relapsed Neuroendocrine Tumors

This is a safety study to determine the recommended dose to test in clinical trials. The study involves two treatments with 212Pb (212-lead) VMT-α-NET. This is a safety study only; it will most likely not provide therapeutic benefit.

开始日期2023-11-10

申办/合作机构

University of Iowa

[+3]

100 项与 [212Pb]VMT-α-NET 相关的临床结果

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100 项与 [212Pb]VMT-α-NET 相关的转化医学

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100 项与 [212Pb]VMT-α-NET 相关的专利（医药）

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项与 [212Pb]VMT-α-NET 相关的文献（医药）

2024-06-01·Clinical nuclear medicine

Charting the Course of Targeted α Therapy With First-in-Human, Postadministration Image-Guided Dosimetry and Response Assessment of 212Pb-VMT-α-NET in Metastatic Neuroendocrine Tumors

Article

作者: Schultz, Michael K. ; Rana, Nishant ; Malik, Dharmender ; Singh, Navneet ; Sen, Ishita B. ; Thakral, Parul

Abstract:

212Pb emerges as a compelling in vivo α-particle generator for targeted α therapy due to its favorable half-life (t1/2 = 10.6 hours) aligning with the biological half-lives of small peptides and its potent α-particle emissions within the decay series. However, one of the challenges with 212Pb is to perform appropriate image-guided dosimetry. To date, all the data have been extrapolated from its imaging analog, 203Pb. We present the first-in-human posttherapy image-guided dosimetric estimates of a single cycle of 212Pb VMT-α-peptide, administered in a 41-year-old woman with an advanced grade 2 NET. The patient also demonstrated partial response on treatment.

项与 [212Pb]VMT-α-NET 相关的新闻（医药）

2025-06-18

·PRNewswire

Cancer Rates Are Surging in Young Adults -- Here's Where the Smart Money Is Going

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 18, 2025 /PRNewswire/ -- USA News Group News Commentary – According to a recent report in Newsweek, more Americans younger than 50 are getting cancer. In fact, the report cites a recent study from the National Institutes of Health (NIH), which found that between 2010 and 2019, more than 2 million Americans aged 15 to 49 were diagnosed with cancer, with early-onset cases rising significantly in 14 different cancer types, including breast, colorectal, and kidney cancers. The dire statistics from the study come at a time where Bloomberg has recently reported on the skyrocketing costs of cancer drugs, and their lack of life-extension successes. That said, with the recent close of the world's largest cancer conference (the 2025 American Society of Clinical Oncology annual meeting), doctors, scientists, and researchers remain optimistic. For investors to note, oncology innovators have provided recent developments to pay attention to, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Galectin Therapeutics, Inc. (NASDAQ: GALT), ProPhase Labs, Inc. (NASDAQ: PRPH), CG Oncology, Inc. (NASDAQ: CGON), and Perspective Therapeutics, Inc. (NYSE-American: CATX). Continue Reading Pelareorep Facts (PRNewsfoto/USA News Group) With reports coming out that the current US administration could drastically reduce funding of the National Cancer Institute (NCI) by nearly 40%, the market is looking towards the private sector to pick up the slack and continue to make advancements in cancer treatment. According to analysts at ResearchAndMarkets, the global oncology market is projected to reach US$866.1 billion by 2034, rising at a 10.8% CAGR, while Vision Research Reports projects the global oncology market to surpass US$903.81 billion by 2034, at a 10.9% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just announced a major leadership transition that could mark a pivotal chapter in its clinical and corporate trajectory. The company has appointed Jared Kelly as Chief Executive Officer and member of the Board, a move that brings in a seasoned biotech dealmaker known for high-value M&A and immuno-oncology strategy. Kelly most recently played a central role (as General Counsel) in the $2 billion sale of Ambrx Biopharma to Johnson & Johnson. Prior to that, he advised numerous biotech firms on licensing and acquisitions during his tenure at leading law firms Kirkland & Ellis LLP and Lowenstein Sandler LLP. In joining Oncolytics, he inherits one of the most intriguing immunotherapy agents and pipelines in clinical oncology: pelareorep, a virus-based agent with broad synergy potential in solid and hematologic tumors. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients," said Jared Kelly, CEO of Oncolytics Biotech. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Kelly's appointment signals a clear priority: advancing pelareorep toward late-stage inflection points with a capital-efficient and partnership-aware strategy. The asset currently holds FDA Fast Track designation in both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC)—a rare distinction that reinforces its regulatory momentum. In trials to date, pelareorep has consistently demonstrated immune activation, synergy with chemotherapies and checkpoint inhibitors, and unusually strong response rates across difficult-to-treat cancers. In metastatic pancreatic cancer (mPDAC), pelareorep has delivered over 60% objective response rates in tumor evaluable patients across Phase 1 and 2 studies—more than double those observed in historical controls— and, separately, two-year survival rates 4-6 times those observed in control patients or in prior studies. In HR+/HER2- metastatic breast cancer, two randomized Phase 2 trials (IND-213 and BRACELET-1) showed meaningful survival benefit. And in anal cancer, early data from a phase 2 cohort combining pelareorep with a checkpoint inhibitor showed partial or complete responses in nearly half of evaluable patients—far exceeding historical norms for monotherapy. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of the Board and outgoing Interim CEO of Oncolytics. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." To align incentives with long-term shareholder value, Kelly's compensation package includes equity and milestone-based awards tied to future strategic transactions and financings. The structure reflects Oncolytics' intention to drive both clinical and corporate progress without overextending its cap table—while remaining attractive to potential collaborators. As multiple programs advance within the GOBLET study—including pancreatic and anal cancer cohorts backed by regulatory support and third-party funding— Oncolytics appears poised to benefit from a combination of scientific traction, capital flexibility, and strategic leadership. Photo - CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Galectin Therapeutics, Inc. (NASDAQ: GALT) is advancing belapectin, a galectin-3 inhibitor with applications in both MASH cirrhosis and oncology, including combination immunotherapy for head and neck cancers. The company recently presented updated data at the 2025 EASL Congress highlighting statistically significant improvements in liver stiffness and reduced varices progression. "This quarter, we remained laser-focused on advancing additional analyses for belapectin," said Joel Lewis, CEO and President of Galectin Therapeutics. "We look forward to sharing more biomarker data as it becomes available." With Fast Track Designation in place, Galectin continues to evaluate expansion into cancer indications pending a development partner. ProPhase Labs, Inc. (NASDAQ: PRPH) has recently reported successful validation of its BE-Smart™ molecular test in detecting esophageal cancer using brush cytology samples, showing a technical success rate above 95%. "The ability to run BE-Smart on brush biopsy samples opens the door to much broader clinical use," said Ted Karkus, CEO of ProPhase Labs. "BE-Smart now stands apart as the only advanced molecular test designed to work with both forceps biopsies and brush-based tissue collection." The company is positioning BE-Smart for near-term commercialization, targeting the $10 billion esophageal disease testing market. With dual compatibility across standard biopsy methods, BE-Smart is designed to improve early detection and risk stratification for deadly cancers like EAC. CG Oncology, Inc. (NASDAQ: CGON) continues to progress its lead candidate cretostimogene, an oncolytic immunotherapy aimed at non-muscle invasive bladder cancer (NMIBC). "With best-in-disease durability and tolerability data from the BOND-003 Cohort C registrational trial recently presented at AUA, we are well positioned to initiate our BLA submission in the second half of the year for the treatment of patients with HR NMIBC unresponsive to BCG," said Arthur Kuan, Chairman and CEO of CG Oncology. "If approved, I'm confident that cretostimogene is well positioned to become backbone therapy in NMIBC, potentially addressing more than 70% of the market opportunity in need of a new and innovative therapy." At the 2025 AUA Annual Meeting, the company reported a 42.3% complete response at 24 months in its BOND-003 Cohort C, with nearly all patients avoiding progression to invasive disease. CG plans to initiate its BLA submission in the second half of 2025 while advancing multiple cohorts across BCG-unresponsive and intermediate-risk populations. Backed by over $688 million in cash and marketable securities, CG Oncology is positioned to reach multiple late-stage milestones over the next 12 months. Perspective Therapeutics, Inc. (NYSE-American: CATX) announced updated Phase 1/2a trial results for [212Pb]VMT-α-NET at the 2025 ASCO Annual Meeting, with promising signs of durability and safety in patients with progressive SSTR2-positive neuroendocrine tumors. "[212Pb]VMT-α-NET is emerging as an exciting potential treatment option for patients with progressive NETs, with continued durability of anti-tumor activity at the dose level used in Cohort 2 and a favorable tolerability profile seen so far," said Vikas Prasad, MD, Associate Professor of Radiology at the Mallinckrodt Institute of Radiology, Siteman Cancer Center. "I am eager to find more treatments to help my patients fight hard against their disease and return to their normal lives." Among nine early patients in Cohorts 1 and 2, seven remained progression-free after a year, with multiple confirmed objective responses now observed. Safety data from 42 total treated patients showed no dose-limiting toxicities, no Grade 4/5 adverse events, and no treatment-related discontinuations. The company is now in discussions with the FDA to finalize dose selection and continue advancement of this alpha-emitting radiotherapeutic platform. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Logo - SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果ASCO会议免疫疗法高管变更快速通道

2025-05-31

·PipelineReview

Perspective Therapeutics Highlights Updated Interim Data from its Ongoing Phase 1/2a Clinical Trial of [212Pb]VMT-α-NET at the 2025 ASCO Annual Meeting

SEATTLE, WA, USA I May 30, 2025 I Perspective Therapeutics, Inc. (“Perspective” or the “Company”) (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, announced that updated interim results from its ongoing Phase 1/2a clinical trial of [ 212 Pb]VMT-α-NET were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3, 2025 in Chicago, Illinois. This Phase 1/2a clinical trial is a multi-center open-label dose escalation and dose expansion study (clinicaltrials.gov identifier NCT05636618 ) of [ 212 Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumors (NETs) who have not received prior radiopharmaceutical therapy (RPT) and whose tumors have shown radiological evidence of disease progression in the 12 months prior to enrollment. Updated interim efficacy data were presented for two patients in Cohort 1 and seven patients in Cohort 2 with a data cut-off date of April 30, 2025. These patients were enrolled for dose limiting toxicities observations. Results with a data cut-off date of January 10, 2025 from these patients were previously presented as a poster at the ASCO Gastrointestinal Cancers Symposium (ASCO-GI) in January 2025. Cohort 2 was reopened for enrollment in August 2024, and through April 30, 2025, a further 33 patients were enrolled in Cohort 2 and had received at least one treatment. Safety data were presented at the ASCO Annual Meeting for all 42 patients who had received at least one treatment with [ 212 Pb]VMT-α-NET. A modest number of patients experienced low grade hematologic toxicities. Observations of lymphocyte count decrease were generally low grade, with three events at Grade 3 and none at Grades 4 or 5. Increases in blood creatinine levels were all at Grade 1. No dysphagia or serious renal complications were reported. Seven out of nine patients in Cohorts 1 and 2 continued to experience disease control and remained in study. One patient experienced stable disease for 48 weeks after their first dose prior to experiencing progressive disease. One patient was previously reported to have progressive disease after one dose under RECIST v1.1, by unambiguous progression of non-target lesions. The first patient who experienced a confirmed objective response remained in response for over 10 months and in study. This patient received the first two [ 212 Pb]VMT-α-NET doses at administered dose of 5.0 mCi (equivalent to 84.6 µCi/kg), then received the remaining two doses at the next lower activity level of 2.5 mCi (equivalent to 42.4 µCi/kg). Two patients experienced initial responses after the end of their treatment periods as of the data cut-off date for the previous data presentation at ASCO-GI. Those responses have since been confirmed in subsequent scans. They remained in response and in study. These patients received four doses of 5.0 mCi (equivalent to 68.7 µCi/kg and 31.7 µCi/kg) of [ 212 Pb]VMT-α-NET. A fourth patient was observed to experience an initial (unconfirmed) response in the seventh scan at 48 weeks after their first dose, which was the third scan conducted after the end of their treatment period. This patient received four doses of 5.0 mCi (equivalent to 49.1 µCi/kg) of [ 212 Pb]VMT-α-NET. As stated in our August 12, 2024 business update for the second quarter of 2024, the observation period was completed for DLTs in seven patients enrolled in Cohort 2 during the second quarter of 2024. With no DLTs observed and minimal toxicity overall, the Safety Monitoring Committee (SMC) recommended proceeding with dose escalation and enrolling additional patients at 5 mCi to better understand efficacy and safety. Based on interactions with the U.S. Food and Drug Administration (FDA) prior to the initiation of patient dosing in this study in late 2023, the decision to dose patients in the next cohort will follow consultation and alignment with the FDA. “[ 212 Pb]VMT-α-NET is emerging as an exciting potential treatment option for patients with progressive NETs, with continued durability of anti-tumor activity at the dose level used in Cohort 2 and a favorable tolerability profile seen so far,” said Vikas Prasad, MD, Associate Professor of Radiology, Mallinckrodt Institute of Radiology, Siteman Cancer Center, Washington University School of Medicine. “I am eager to find more treatments to help my patients fight hard against their disease and return to their normal lives. I look forward to continuing to evaluate [ 212 Pb]VMT-α-NET as a new option to help my patients, by participating in this study.” Markus Puhlmann, Chief Medical Officer of Perspective, commented, “We are encouraged by the exciting overall clinical profile already observed at the dose level used in Cohort 2. The robust participation in the re-opened Cohort 2 in this dose finding study of [ 212 Pb]VMT-α-NET enables us to learn more about how [ 212 Pb]VMT-α-NET can benefit patients and fit into the current treatment paradigm. We plan to submit longer safety follow-up data for all patients enrolled in the study and preliminary efficacy data for a subgroup for presentation at a scientific congress in the second half of this year. In keeping with the commitment we made to the FDA prior to the start of dosing in this study, we are engaging with the FDA as we wish to continue to pursue dose finding for [ 212 Pb]VMT-α-NET. An update will be provided once alignment is reached with the agency.” Thijs Spoor, Chief Executive Officer of Perspective, commented, “[ 212 Pb]VMT-α-NET is progressing expeditiously as one of three potential new medicines in clinical development based on our next generation targeted radiopharmaceutical technology platform. We continue to evaluate opportunities to enhance our operations and infrastructure so we can support patient demand for all of our programs.” Perspective will webcast a conference call on Monday, June 2, 2025 at 8:00 am ET to discuss the data presented at the ASCO Annual Meeting. Webcast details are available on the Events page of the Company’s website. Dr. Prasad will participate, along with members of Perspective’s management team. A live question and answer session will follow the formal presentation. About [ 212 Pb]VMT-α -NET Perspective designed [ 212 Pb]VMT-α-NET to target and deliver 212 Pb to tumor sites expressing SSTR2. The Company is conducting a multi-center, open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05636618 ) of [ 212 Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors who have not received prior radiopharmaceutical therapies (RPT). Results with a data cut-off date of January 10, 2025 from the first nine patients enrolled into Cohorts 1 and 2 of the study were previously presented as a poster at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium ( ASCO-GI ) in January 2025. Cohort 2 was reopened in August 2024. During 2H 2025, some of the 33 patients enrolled after the cohort reopened and through April 30, 2025, will have had the opportunity for at least 32 weeks of follow-up after their initial doses, sufficient time to receive at least one scan after their full treatment (up to four doses every eight weeks), if they receive all four doses of treatment per protocol. About Neuroendocrine Tumors Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. According to cancer.net, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors and as a result, there are over 170,000 people living with this diagnosis. 1 About Perspective Therapeutics, Inc. Perspective Therapeutics, Inc. is a radiopharmaceutical development company that is pioneering advanced treatments for cancers throughout the body. The Company has proprietary technology that utilizes the alpha-emitting isotope 212 Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. The Company is also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This “theranostic” approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity. The Company’s melanoma (VMT01), neuroendocrine tumor (VMT-α-NET) and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials in the U.S. The Company is growing its regional network of drug product candidate finishing facilities, enabled by its proprietary 212 Pb generator, to deliver patient-ready product candidates for clinical trials and commercial operations. For more information, please visit the Company’s website at www.perspectivetherapeutics.com . 1 Wu P, He D, Chang H, Zhang X. Epidemiologic trends of and factors associated with overall survival in patients with neuroendocrine tumors over the last two decades in the USA. Endocr Connect . 2023;12(12):e230331. Published 2023 Nov 23. doi:10.1530/EC-23-0331. SOURCE: Perspective Therapeutics

临床结果ASCO会议放射疗法临床研究

2024-01-11

·Firstwordpharma

FDA agrees to review generic of Novartis radoligand therapy Lutathera

Lantheus announced Thursday that the FDA has accepted its application to market a generic version of Novartis' Lutathera (lutetium Lu 177 dotatate). The radiopharmaceutical is currently approved in the US as a treatment for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (NETs) in adults.If the FDA signs off on the generic version, dubbed 177Lu-PNT2003, Lantheus said it believes it would be the first applicant to have filed a substantially complete ANDA for Lutathera containing a Paragraph IV certification under provisions of the Hatch-Waxman Act, and that it would be eligible for 180 days of generic marketing exclusivity in the US.Lutathera became the first peptide receptor radionuclide therapy to secure approval when the FDA signed off on it in 2018. That decision was based on pivotal NETTER-1 data showing that adding it to standard care with octreotide LAR led to a 79% reduction in the risk of disease progression or death in patients with inoperable midgut NETs, compared to octreotide LAR alone. The treatment was originally developed by Advanced Accelerator Applications, which was subsequently acquired by Novartis for around $3.9 billion.Lantheus licensed commercialisation rights to 177Lu-PNT2003, along with another radiotherapeutic agent, from POINT Biopharma at the end of 2022 for up to $2.2 billion. Earlier this week, Lantheus also paid $28 million upfront for an option to exclusively license Perspective Therapeutics' radiopharmaceutical Pb212-VMT-⍺-NET, which is in a Phase I/II trial to treat NETs.Meanwhile, Novartis has been working to boost its manufacturing capabilities for radioligand therapies, including the prostate cancer treatment Pluvicto (lutetium 177 vipivotide tetraxetan). Last week, the company announced that the FDA had authorised a new production facility in Indianapolis, Indiana.

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100 项与 [212Pb]VMT-α-NET 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
胃肠道神经内分泌肿瘤	临床2期	美国	National Cancer Institute	2025-02-07
SSTR阳性胃肠胰神经内分泌肿瘤	临床2期	美国	National Cancer Institute	2025-02-07
类癌	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
胃神经内分泌肿瘤	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
胃肠胰神经内分泌肿瘤	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
神经内分泌癌	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
肺神经内分泌肿瘤	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
胰腺神经内分泌肿瘤	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
嗜铬细胞瘤	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
小细胞肺癌	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27