Lantheus Announces the First and Only FDA Cleared AI-Enabled PSMA Digital Application, aPROMISE™, Strengthening Lantheus’ Leadership in Prostate Cancer


2021-07-31 05:30:03 BioSpace


aPROMISE was developed to quantify and standardize assessment of PSMA PET/CT images and will support PYLARIFY® adoption in the U.S. NORTH BILLERICA, Mass.--(BUSINESS WIRE)-- Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus) announced today that its subsidiary, EXINI Diagnostics AB, was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its digital application, aPROMISE™ (automated PROstate Cancer Molecular Imaging Standardized Evaluation). Clinicians will have the option to utilize aPROMISE with PYLARIFY® (piflufolastat F 18) to increase the efficiency and reproducibility of their PSMA PET/CT assessments. PYLARIFY was recently approved by the FDA and is the first and only commercially available PSMA-targeted PET imaging agent for prostate cancer. aPROMISE is an artificial intelligence-based, medical device software that uses a deep learning algorithm trained and validated across over 3,000 PSMA images to date, to allow healthcare professionals and researchers to perform quantitative assessment of PSMA PET/CT images in prostate cancer. The PROMISE criteria were developed by leading experts in prostate cancer imaging to standardize quantitative evaluation of prostate cancer lesions by location using prostate-specific membrane antigen (PSMA) PET/CT.1 aPROMISE facilitates rapid and robust quantification of prostate cancer lesions in anatomical context, enabling clinicians to make routine use in the clinic of a comprehensive, automated approach to patient evaluation. aPROMISE includes a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions in their anatomical context. aPROMISE provides enhanced consistency in quantitative analysis and standardized reports and has demonstrated increased efficiency and reproducibility of clinicians’ PSMA PET/CT image assessments.2,3 “Lantheus is pleased with the FDA clearance of aPROMISE, our AI-enabled digital application that expands our PSMA platform,” said Etienne Montagut, Chief Business Officer for Lantheus. “We are excited to provide such an innovative tool for PSMA quantification and reporting that can empower clinicians to make more informed treatment decisions for their prostate cancer patients.” aPROMISE Indications for Use aPROMISE is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis. About Prostate Cancer Prostate cancer is the second most common form of cancer affecting men in the United States -- an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, almost 250,000 new cases of prostate cancer will be diagnosed, and more than 30,000 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.4 About PYLARIFY® (piflufolastat F 18) Injection PYLARIFY® (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope5 for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.6-10 PYLARIFY® (piflufolastat F 18) Injection Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Important Safety Information Contraindications None. Warnings and Precautions Risk of Image Misinterpretation Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Hypersensitivity Reactions Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available. Radiation Risks Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. Adverse Reactions The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions. Drug interactions Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established. To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or For important risk and use information about PYLARIFY Injection, please see Full Prescribing information. About Lantheus Holdings, Inc. Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit Safe Harbor for Forward-Looking and Cautionary Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “anticipate,” “believe,” “confident,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “will” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the Company’s ability to successfully launch aPROMISE as a commercial product; (ii) the market receptivity to aPROMISE as a new digital application; (iii) the intellectual property protection of aPROMISE; (iv) interruptions or performance problems associated with our digital application, including a service outage; (v) a network or data security incident that allows unauthorized access to our network or data or our customers’ data; and (vi) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q), including, but not limited to those related to PYLARIFY. 1Eiber M, Herrmann K, Calais J, Hadaschik B, Giesel FL, Hartenbach M, et al. Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE): Proposed miTNM Classification for the Interpretation of PSMA-Ligand PET/CT. Journal of nuclear medicine: official publication, Society of Nuclear Medicine. 2018;59(3):469-78. 2Nickols N, Anand A, Johnsson K, Brynolfsson J, Borrelli P, Juarez J, et al. aPROMISE: A Novel Automated-PROMISE platform to Standardize Evaluation of Tumor Burden in (18)F-DCFPyL (PSMA) images of Veterans with Prostate Cancer. Journal of nuclear medicine: official publication, Society of Nuclear Medicine. May 2021. 3Johnsson K, Brynolfsson J, Sahlstedt H, Nickols N, Rettig M, Probst S, Morris M, Bjartell A, Eiber M, Anand A, Analytical Performance of aPROMISE: Automated Anatomic Contextualization, Detection and Quantification of [18F]DCFPyL (PSMA) Imaging for Standardized Reporting: official Publication, EJNMMI. July 2021 4American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, GA. 2021. 5Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.2020191689 6Mena et al. 18 F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy J Nucl Med 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1. 7Alipour et al. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019; 11: 1758835919876828. 8Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894. 9Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-0290 10PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company View source version on Mark Kinarney Senior Director, Investor Relations 978-671-8842 Melissa Downs Director, Corporate Communications 646-975-2533 Source: Lantheus Holdings, Inc. View this news release online at:
aPROMISE的开发是为了量化和标准化PSMA PET/CT图像的评估,并将支持Pylarify®在美国的采用。 马萨诸塞州北比勒里卡--(商业网)--兰修斯控股公司(纳斯达克代码:LNTH)(兰修斯)今天宣布,其子公司EXINI Diagnostics AB因其数字应用APromise™(自动化前列腺癌分子成像标准化评估)获得美国食品药品监督管理局(FDA)的510(k)许可。临床医生可以选择使用aPROMISE与Pylarify®(piflufolastat F18),以提高PSMA PET/CT评估的效率和重复性。PYLARIFY最近被FDA批准,是第一个也是唯一一个商业化的PSMA靶向前列腺癌PET显像剂。 aPROMISE是一款基于人工智能的医疗设备软件,使用迄今为止在3000多张PSMA图像中训练和验证的深度学习算法,允许医疗保健专业人员和研究人员对前列腺癌PSMA PET/CT图像进行定量评估。PROMISE标准是由前列腺癌成像领域的领先专家开发的,旨在通过使用前列腺特异性膜抗原(PSMA)PET/CT.1通过定位来标准化前列腺癌病变的定量评估。aPROMISE有助于在解剖学背景下快速和稳健地定量前列腺癌病变,使临床医生能够在临床上常规使用一种全面、自动化的方法来评估患者。aPROMISE包括一个解决方案,用于自动分割和标记身体,量化和报告其解剖背景下的可疑病变。aPROMISE在定量分析和标准化报告方面提供了更高的一致性,并证明了临床医生PSMA PET/CT图像评估的更高效率和可重复性。2,3 兰修斯首席业务官艾蒂安·蒙塔古特(Etienne Montagut)表示:“兰修斯对美国食品和药物管理局批准aPROMISE感到高兴,这是我们的人工智能数字应用程序,扩展了我们的PSMA平台。”“我们很高兴为PSMA量化和报告提供这样一种创新的工具,可以使临床医生为他们的前列腺癌患者做出更知情的治疗决定。” 承诺使用指示 aPROMISE的目的是供医疗保健专业人员和研究人员用于数字医学图像的接受、传输、存储、图像显示、操作、量化和报告。该系统旨在与使用PSMA、PET/CT的核医学(NM)成像获得的图像一起使用。该设备提供了通用的图像存档和通信系统(PACS)工具,以及肿瘤学的临床应用,包括感兴趣区域的标记和定量分析。 关于前列腺癌 在美国,前列腺癌是影响男性的第二大常见癌症--估计八分之一的男性一生中会被诊断患有前列腺癌。美国癌症协会估计,2021年,将有近25万新的前列腺癌病例被确诊,超过3万名男性死于该病。美国目前约有310万男性认为自己是前列腺癌的幸存者。4 关于吡拉菲®(匹氟福司他F18)注射液 Pylarify®(piflufolastat F18)注射液(也称为18F-DCFPYL或PyL)是一种氟化小分子PSMA靶向PET显像剂,能够显示淋巴结、骨和软组织转移,以确定是否存在复发和/或转移性前列腺癌。对于患有前列腺癌的男性,PYLARIFY PET结合了PET成像的准确性,PSMA靶向的精确性和F18放射性同位素5的清晰度,以获得优越的诊断性能。推荐的吡喹酮剂量为333 MBq(9 mCi),可接受的范围为296 MBQ-370 MBq(8 mCI-10 mCi),以静脉注射的方式给药。6-10 吡拉菲®(匹氟福司他F18)注射液 指示 Pylarify®(piflufolastat F18)注射液是一种用于男性前列腺癌前列腺特异性膜抗原(PSMA)阳性病变正电子发射断层扫描(PET)的放射性诊断剂: 怀疑有转移的人是最初明确治疗的候选者。 根据血清前列腺特异性抗原(PSA)水平升高怀疑复发。 重要安全信息 禁忌症 一个都没有。 警告及预防措施 形象曲解风险 PYLARIFY成像可能会出现成像解释误差。阴性图像不排除前列腺癌的存在,阳性图像不能确认前列腺癌的存在。PYLARIFY对有生化证据的前列腺癌复发患者的显像性能似乎受到血清PSA水平的影响。PYLARIFY对盆腔转移淋巴结的显像效果似乎受到Gleason评分和肿瘤分期等危险因素的影响。PYLARIFY摄取对前列腺癌没有特异性,可能发生在其他类型的癌症以及非恶性过程和正常组织中。推荐临床相关性,可能包括可疑前列腺癌部位的组织病理学评估。 过敏反应 监测病人的过敏反应,特别是对其他药物和食物过敏的病人。反应可能会延迟。始终有训练有素的工作人员和复苏设备可用。 辐射风险 诊断性放射性药物,包括吡喹酮,使病人暴露在辐射之下。辐射暴露与剂量依赖的癌症风险增加有关。确保安全的处理和准备程序,以保护病人和医护人员免受无意的辐射照射。建议患者用药前后补水,用药后勤脱空。 不良反应 在Pylarify的临床研究中,最常见的不良反应是头痛、睡眠障碍和疲劳,发生率≤2%。此外,迟发性超敏反应报告在一个病人(0.2%)有过敏反应史。 药物相互作用 雄激素剥夺治疗(ADT)和其他靶向雄激素途径的治疗,如雄激素受体拮抗剂,可能导致前列腺癌中吡喃的摄取改变。这些疗法对PYLARIFY PET性能的影响尚未确定。 若要报告PYLARIFY的可疑不良反应,请拨打1-800-362-2668或联系美国食品和药物管理局1-800-FDA-1088或。 有关吡拉菲注射液的重要风险和使用信息,请参阅完整的处方信息。 关于兰修斯控股公司。 Latheus Holdings,Inc.是Latheus Medical Imaging,Inc.、Progenics Pharmaceuticals,Inc.和EXINI Diagnostics AB的母公司,是致力于创新影像诊断、靶向治疗和人工智能解决方案的老牌领导者和全面集成的供应商,以发现和跟随®严重的医疗状况。兰修斯提供广泛的产品组合,包括超声心动图剂定义®瓶(Perflutren脂质微球)注射悬浮液;Pylarify®,一种PSMA PET显像剂,用于检测疑似复发或转移的前列腺癌;Technelite®(锝Tc99m发生器),一种基于锝的发生器,提供核医学程序中使用的基本医用同位素;阿兹拉®治疗某些罕见的神经内分泌肿瘤;和Relistor®治疗阿片类药物引起的便秘,该公司与Bausch Health Companies,Inc.合作。该公司总部设在马萨诸塞州的北比勒里卡,在纽约、新泽西、加拿大和瑞典设有办事处。欲了解更多信息,请访问。 前瞻性和警示性陈述的避风港 本新闻稿包含经修订的1995年《私人证券诉讼改革法》含义内的“前瞻性陈述”,这些陈述受到风险和不确定性的影响,是根据经修订的1933年《证券法》第27A条和经修订的1934年《证券交易法》第21E条的安全港条款做出的。前瞻性陈述可以通过使用诸如“预期”、“相信”、“有信心”、“可能”、“估计”、“预期”、“打算”、“可能”、“计划”、“预测”、“项目”、“目标”、“意愿”等术语来识别,以及其他类似术语。此类前瞻性陈述基于当前的计划、估计和预期,这些计划、估计和预期受到风险和不确定性的影响,这些风险和不确定性可能导致实际结果与前瞻性陈述中描述的结果存在重大差异。纳入前瞻性陈述不应被视为表示此类计划、估计和预期将会实现。请读者不要过度依赖本文所载的前瞻性陈述,这些陈述仅限于本文所述日期。本公司没有义务公开更新任何前瞻性声明,无论是由于新的信息、未来的发展或其他原因,除非法律可能要求。可能导致我们的实际结果与前瞻性陈述中描述的结果有重大差异的风险和不确定性包括(i)公司成功推出aPROMISE作为商业产品的能力;(ii)市场对aPROMISE作为新数码应用的接受程度;(iii)承诺的知识产权保护;(iv)与数码应用程序有关的中断或性能问题,包括服务中断;(v)网络或数据安全事故,允许未经授权访问我们的网络或数据或我们客户的数据;以及(vi)我们向证券交易委员会提交的文件中讨论的风险和不确定性(包括我们关于表格10-K的年度报告和我们关于表格10-Q的季度报告中风险因素一节中描述的风险和不确定性),包括但不限于与Pylarify有关的风险和不确定性。 1Eiber M,Herrmann K,Calais J,Hadaschik B,Giesel FL,Hartenbach M,等人。前列腺癌分子影像标准化评估(PROMERE):为PSMA配体PET/CT的解释提出了miTNM分类。核医学杂志:官方出版物,核医学学会。2018;59(3):469-78。 2Nickols N,Anand A,Johnsson K,Brynolfsson J,Borrelli P,Juarez J,等人。APromise:一个新的自动化Promise平台,用于标准化评估退伍军人前列腺癌(18)F-DCFPyL(PSMA)图像中的肿瘤负担。核医学杂志:官方出版物,核医学学会。2021年5月。 3Johnsson K,Brynolfsson J,Sahlstedt H,Nickols N,Rettig M,Probst S,Morris M,Bjartell A,Eiber M,Anand A,Apromise的分析性能:用于标准化报告的[18F]DCFPYL(PSMA)成像的自动化解剖背景化、检测和量化:官方出版物,EJNMMI。2021年7月 4美国癌症协会。2021年事实与数字。美国癌症协会。佐治亚州亚特兰大。2021年。 5Tan N,Oyoyo U,Bavadian N,et al.PSMA靶向放射示踪剂与18F氟氯丙烷检测前列腺癌明确治疗后生化复发的比较:系统评价和荟萃分析。放射学。2020;296:44-55。DOI:10.1148/radiol.2020191689 6Mena等人。18 F-DCFPyL PET/CT显像在原发局部治疗后生物化学复发前列腺癌患者中的应用J Nucl Med2020 Jun;61(6):881-889。Doi:10.2967/jnumed.119.234799。Epub 2019年11月1日。 7Alipour等人。前列腺癌治疗的指导管理:从常规影像学转向PSMA PET是时候了?这是医学上的。2019年;11:1758835919876828。 8Werner等18F标记,PSMA靶向放射性示踪剂:利用放射性氟化的优势进行前列腺癌分子成像实验2020;10(1):1-16。DOI:10.7150/Thno.37894。 9Petersen LJ,Zacho HD。PSMA PET对中高危前列腺癌原发淋巴结分期的快速系统评价。癌症成像。2020;20(1):1-8。DOI:10.1186/S40644-020-0290 10 pylarify®[包装插入物]。马萨诸塞州North Billerica:Progenics Pharmaceuticals,Inc. 在businesswire.com查看源代码版本: 马克·基纳尼 投资者关系高级总监 978-671-8842 梅丽莎·唐斯 企业传讯总监 646-975-2533 资料来源:兰修斯控股公司。 在网上查看此新闻稿: