Flutemetamol F-18

GE HealthCare’s FDA-approved flurpiridaz F 18 PET radiotracer, Flyrcado, delivers higher diagnostic efficacy in patients with known or suspected coronary artery disease (CAD), compared to SPECT MPI, the predominant procedure used in nuclear cardiology today With a half-life over ten times longer than currently approved cardiac PET radiotracers, Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD Available as a unit dose - or ready-to-use, Flyrcado has the potential to expand clinician and patient access to PET myocardial perfusion imaging (MPI) ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of Flyrcado™ (flurpiridaz F 18) injection, a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD). Indicated for patients with known or suspected CAD, Flyrcado delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today. Flyrcado, which can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, has the potential to expand clinician and patient access to PET MPI, including improving diagnostic accuracy in difficult-to-image patients such as those with a high body mass index (BMI) and women 1 . With a half-life of 109-minutes—significantly longer than existing PET MPI tracers—Flyrcado removes the need for on-site tracer production and generator maintenance and enables distribution to a wide network of hospitals and imaging centers. This longer half-life also means Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD, enabling the most robust protocol for evaluating ischemia in patients. Furthermore, clinicians would have the ability to rescan a patient during the same imaging session in the event of technical difficulties, rather than rescheduling an additional scan. Dr. Jamshid Maddahi, MD, FACC, MASNC, principal investigator of the Flyrcado clinical trials, clinical professor of medicine (cardiology) and molecular and medical pharmacology (nuclear medicine) at UCLA School of Medicine and director of the Biomedical Imaging Institute, said, “Flyrcado is the most exciting development in the field of nuclear cardiology over the past few decades. Although PET MPI as a modality enables high diagnostic accuracy as compared to SPECT MPI 2 , only a minority of annual PET scans in the US are PET MPI because of limited access to the currently available PET tracers—which may be addressed with the introduction of Flyrcado. I am excited for this new radiotracer and its potential impact, as a game changer, for diagnosing the disease with the highest mortality rate in the world.” CAD is the most common form of heart disease and remains the leading cause of death for men and women in the U.S. 3 , with 695,000 deaths recorded in 2021 4 . During the multicenter international AURORA Phase III trial, flurpiridaz F 18 was compared with both invasive coronary angiography as a standard of truth to determine diagnostic efficacy in detecting CAD, as well as with SPECT MPI. Around six million MPI procedures are undertaken each year in the U.S. 5 to show blood flow through the heart muscle, and evaluate the presence, extent and degree of myocardial ischemia or infarction. Dr. Mouaz Al-Mallah, MD, MSc, MASNC, immediate Past President of the American Society of Nuclear Cardiology (ASNC) and Director of Cardiac PET at Houston Methodist Hospital, said “Given the desirable properties of flurpiridaz F 18, both in terms of myocardial uptake and fluorine-18 imaging characteristics, Flyrcado represents a favorable combination of imaging agent pharmacology and convenience to imaging institutions and patients. There are new frontiers for cardiac PET that this tracer can achieve; it can be ordered as a unit dose, and it offers the flexibility to perform exercise stress testing. We expect new imaging centers to be able to offer cardiac PET to their patients, making it more convenient to access PET MPI and providing a meaningful impact for clinicians and their patients.” Kevin O’Neill, CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare, said, “As the first and only FDA-approved F 18 PET MPI radiotracer for CAD detection, Flyrcado can make a real difference to clinicians and their patients. This is another example of GE HealthCare’s commitment to innovating and investing to shape the future of molecular imaging, increasing diagnostic confidence and addressing unmet patient needs.” Flyrcado is one of three F 18 imaging agents in GE HealthCare’s portfolio of FDA-approved molecular imaging PET products, joining radiopharmaceutical PET imaging agents Cerianna™ (fluoroestradiol F 18) injection, used to detect estrogen receptor positive lesions as an adjunct to biopsy in patients with metastatic and recurrent breast cancer, and Vizamyl™ (flutemetamol F 18) injection which is a PET tracer for imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients who are being evaluated for Alzheimer’s disease or other causes of cognitive decline. GE HealthCare acquired exclusive global commercialization rights for flurpiridaz F 18 from Lantheus in 2017 and has led the funding and development of the product through to approval. Lantheus collaborated on the development and will also collaborate on commercialization through a joint steering committee. Lantheus is entitled to royalties based on commercial sales milestones. Flyrcado will be available in initial U.S. markets in early 2025 with expanding availability thereafter. As a leading global medical technology and pharmaceutical diagnostics innovator, GE HealthCare provides both molecular imaging equipment and proprietary radiopharmaceuticals used across cardiology, neurology and oncology. The PDx segment is a global leader in imaging agents used to support over 120 million patient procedures per year globally, equivalent to four patient procedures every second. About GE HealthCare Technologies Inc. GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits. Follow us on LinkedIn , X , Facebook , Instagram , and Insights for the latest news, or visit our website for more information. INDICATIONS AND USAGE OF FLYRCADO™: FLYRCADO™ (flurpiridaz F 18) injection, for intravenous use important safety information IMPORTANT SAFETY INFORMATION Indications and Usage FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction. Contraindications None Warnings and Precautions Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information. Radiation risks: FLYRCADO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void. Adverse Reactions Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia. Use in Specific Populations Pregnancy There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure. FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy. Lactation Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration. Pediatric Use Safety and effectiveness of FLYRCADO in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800-FDA-1088 or For full prescribing information, click here . For important safety information, please click here . INDICATIONS AND USAGE OF CERIANNA™: INDICATIONS AND USAGE CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR). CONTRAINDICATIONS None. ADVERSE REACTIONS In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare Company at 800.654.0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 1-800-FDA-1088 or . For full Prescribing Information click here . INDICATIONS AND USAGE OF VIZAMYL™: PRODUCT INDICATIONS AND USE VIZAMYL™ (Flutemetamol F 18) injection is indicated for positron-emission tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of cognitive decline. A negative scan indicates sparse to no neuritic plaques, inconsistent with a diagnosis of AD at the time of image acquisition. A negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive scan indicates moderate to frequent amyloid neuritic plaques. This amount of amyloid neuritic plaque has been shown to be present in patients with AD but may also be present in patients with other neurologic conditions as well as in older people with normal cognition. Vizamyl is an adjunct to other diagnostic evaluations. Limitations: A positive scan does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of Vizamyl have not been established for predicting the development of dementia or other neurologic conditions or for monitoring responses to therapies. Important Safety Information About VIZAMYL ™ (Flutemetamol F 18) injection CONTRAINDICATIONS • Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80 ADVERSE REACTIONS • The most commonly reported adverse reactions in clinical trials were flushing (2%), increased blood pressure (2%), headache (1%), nausea and dizziness (1%) For full prescribing information, including additional important safety information, please click here . 1 Maddahi J, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, BermanDS, Dorbala S, Garcia EV, Feldman J, Heller GV, Knuuti JM, Martinez-Clark P, Pelletier-Galarneau M, Shepple B, Tamaki N, Tranquart F, Udelson JE. Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients with Suspected Coronary Artery Disease. J AmColl Cardiol. 2023; 82:1598–1610 2 Schindler, T. H., Bateman, T. M., Berman, D. S., Chareonthaitawee, P., De Blanche, L. E., Dilsizian, V., Dorbala, S., Gropler, R. J., Shaw, L., Soman, P., Winchester, D. E., Verberne, H., Ahuja, S., Beanlands, R. S., Di Carli, M. F., Murthy, V. L., Ruddy, T. D., & Schwartz, R. G. (2020). Appropriate use criteria for PET myocardial perfusion imaging. Journal of Nuclear Medicine, 61 (8), 1221-1265. 3 Friede A, O’Carroll PW, Thralls RB, Reid JA. CDC WONDER on the web. Proc AMIA Annu Fall Symp. 1996:408–412. 4 Tsao CW, Aday AW, Almarzooq ZI, et al. Heart disease and stroke statistics—2023 update: A report from the American Heart Association. Circulation. 2023;147: e93–e621. . 5 Miller, R. J. H., Bednarski, B. P., Pieszko, K., Kwiecinski, J., Williams, M. C., Shanbhag, A., Liang, J. X., Huang, C., Sharir, T., Hauser, M. T., Dorbala, S., Di Carli, M. F., Fish, M. B., Ruddy, T. D., Bateman, T. M., Einstein, A. J., Kaufmann, P. A., Miller, E. J., Sinusas, A. J., Acampa, W., Han, D., Dey, D., Berman, D. S., & Slomka, P. J. (2024). Clinical phenotypes among patients with normal cardiac perfusion using unsupervised learning: A retrospective observational study. EBioMedicine , 99, 104930. Contacts GE HealthCare Media Contact: Emmy Elguizaoui +1 (978) 243-7503 Emmy.Elguizaoui@gehealthcare.com

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.