Latest news with #JitSaini
Yahoo
25-06-2025
- Health
- Yahoo
GE HealthCare's PET imaging agent gains Alzheimer's label expansion
The US Food and Drug Administration (FDA) has expanded the indications of an imaging agent developed by GE HealthCare, which will likely put it at the forefront of the Alzheimer's diagnostics arena. The updated label for GE HealthCare's positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F 18 injection) now includes quantification of amyloid in the brain, meaning patients taking an anti-amyloid therapy can be monitored for the drug's effectiveness. There are currently two anti-amyloid therapies approved in the US, namely Eisai/Biogen's Leqembi (lecanemab) and Eli Lilly's Kisunla (donanemab). Despite reimbursement challenges for the two drugs, revenue for them is expected to surge in the coming decade. However, patients seeking to take them must meet stringent criteria, and the therapy's ongoing use comes with caveats – all of which must be diagnostically monitored with PET imaging. City of Hope National Medical Center's radiology professor Phillip Kuo said: 'The use of quantification in amyloid PET imaging has steadily moved from research to clinical practice, where it can aid in more confident and accurate diagnosis. 'Now quantification can also play a critical role in initiating and monitoring amyloid-targeted therapy for Alzheimer's disease and determining when it can be discontinued.' Vizamyl was first approved in 2013 to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment. Now, visual estimation has turned into quantification, opening further diagnostic avenues for the imaging agent in Alzheimer's. In another boost for patients, the label update also adds an explicit indication for the selection of patients eligible for therapy. Effectively, the expansion now allows for the diagnosis of Alzheimer's. This has been based on revised criteria from the Alzheimer's Association, indicating that an abnormal amyloid PET scan is sufficient to establish a diagnosis. The updated label also removes a previous restriction on predicting cognitive decline or progression to dementia, reflecting new evidence that links amyloid-positive scans with a higher risk of advancing from early mild cognitive impairment to Alzheimer's dementia. Whilst there are other available amyloid diagnostics such as Lilly's Amyvid (florbetapir), these do not have the same current range of label indications as Vizamyl. GE HealthCare also has some of the most advanced PET devices on the market. According to analysis by GlobalData, the company has the largest global market share of nuclear imaging equipment, of which PET scanners are a segment. 'The inclusion of quantification and removal of the therapy monitoring limitation from the Vizamyl label is good news for healthcare providers and their patients, further enabling timely and appropriate care decisions,' said GE HealthCare's pharmaceutical diagnostics division's chief medical officer Jit Saini. Research into Alzheimer's diagnosis is gaining momentum amid the revenue ceiling for anti-amyloid therapies. Last month, the FDA approved the Lumipulse G test, the first blood test to help diagnose the disease. The agency said the new tool could help reduce the number of PET scans, which are expensive and radiation-exposing. Developed by Fujirebio Diagnostics, the test measures the ratio between tau and amyloid proteins in the blood and ties its findings to the likelihood of finding plaque buildups in the brain. "GE HealthCare's PET imaging agent gains Alzheimer's label expansion" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
24-06-2025
- Health
- Yahoo
FDA Approves Expanded Indications for GE HealthCare's Vizamyl PET Imaging Agent for Beta Amyloid Detection, Enabling More Precise Care for Alzheimer's Patients
The FDA has approved an updated label for Vizamyl (flutemetamol F 18 injection), including quantification which enables a more continuous and objective measure of amyloid in the brain This approval also enables clinicians to use Vizamyl to monitor patient response to anti-amyloid therapies Other updates include now enabling the use of Vizamyl to predict development of dementia or other cognitive decline due to Alzheimer's disease, selecting patients who are indicated for anti-amyloid therapies, and establishing a diagnosis of Alzheimer's disease. The updated label enables enhanced decision making, and more confident diagnosis and monitoring of Alzheimer's disease, helping patients and their families access timely, precision care. ARLINGTON HEIGHTS, Ill., June 24, 2025--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for its positron emission tomography (PET) imaging agent VizamylTM (flutemetamol F 18 injection) for beta-amyloid detection. The revised label, effective immediately, expands the indications for use, enables quantitative analysis of Vizamyl scans, and removes significant previous limitations such as monitoring patient response to anti-amyloid therapy. Up to now, amyloid diagnostics such as Vizamyl have been used to provide a visual assessment of amyloid plaque accumulation in the brain. With quantification now added to the label, clinicians can reach a more objective assessment, using software that enables a calculation of amyloid load, with published research demonstrating that quantification improves diagnostic confidence and consistency among readers1,2,3. In addition, with the removal of a limitation of use for monitoring therapy effectiveness, Vizamyl can also now be used to assess whether the level of amyloid plaques has been reduced sufficiently for the therapy to potentially be stopped. "The inclusion of quantification and removal of the therapy monitoring limitation from the Vizamyl label is good news for healthcare providers and their patients, further enabling timely and appropriate care decisions," said Jit Saini, MD, Chief Medical Officer of the Pharmaceutical Diagnostics (PDx) division of GE HealthCare. "These changes pave the way for clinicians to expand their usage of Vizamyl, with meaningful implications for patients and their families— helping provide clearer answers, earlier diagnoses, and enabling more personalized treatment strategies." "The use of quantification in amyloid PET imaging has steadily moved from research to clinical practice, where it can aid in more confident and accurate diagnosis," said Phillip Kuo, MD, PhD, FACR, Professor of Radiology, Section Chief of Nuclear Medicine and Director Theranostics at City of Hope National Medical Center. "Now quantification can also play a critical role in initiating and monitoring amyloid-targeted therapy for Alzheimer's disease and determining when it can be discontinued." The label update also adds an explicit indication for selection of patients eligible for therapy and removes several previous limitations of use, including for the diagnosis of Alzheimer's disease, based on revised criteria from the Alzheimer's Association, indicating that an abnormal amyloid PET scan is sufficient to establish a diagnosis. Furthermore, the label now removes a previous limitation on predicting the cognitive decline or progression to dementia, based on evidence linking amyloid-positive scans to a higher risk of progression from the early mild cognitive impairment phase of Alzheimer's dementia4. Vizamyl was first approved in 2013 to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment. GE HealthCare offers solutions for quantitative analysis of amyloid PET scans including through its MIM Neuro Software platform which has been recently FDA cleared for centiloid scaling. GE HealthCare's Pharmaceutical Diagnostics division is a global leader in imaging agents used to support around 130 million procedures per year globally, equivalent to four patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology, with an innovative pipeline, all aimed at enabling better informed diagnosis and monitoring for improved therapy decision making and clinical outcomes. Learn more about Vizamyl at GE HealthCare's PDx booth 1029 at the SNMMI 2025 Annual Meeting June 21 – 24 in New Orleans, LA or online here: About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems 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 care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. GE HealthCare is proud to be among 2025 Fortune World's Most Admired Companies™. Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website for more information. The Alzheimer's Association makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Important Safety Information for VizamylTM (flutemetamol F18) injection PRODUCT INDICATIONS AND USE VIZAMYL™ (flutemetamol F 18 injection) is indicated for positron-emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing of information of the therapeutic products. CONTRAINDICATIONS VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80. WARNINGS AND PRECAUTIONS Anaphylaxis and Other Serious Hypersensitivity Reactions: Serious hypersensitivity reactions including anaphylaxis, presenting with flushing, dyspnea, and hypotension have been observed within minutes following administration and may occur in patients with no history of exposure to VIZAMYL. Obtain a history of allergy or hypersensitivity reactions. Always have resuscitation equipment and trained personnel immediately available at the time of VIZAMYL administration. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy. VIZAMYL is contraindicated in patients with a history of hypersensitivity to VIZAMYL or polysorbate 80. Risk of Image Misinterpretation and Other Errors: Errors may occur in the estimation of amyloid beta neuritic plaque density during VIZAMYL image interpretation. The use of clinical information in the interpretation of VIZAMYL images has not been evaluation and may lead to an inaccurate assessment. Extensive brain atrophy and motion artifacts that distort the image may limit the ability to distinguish gray and white matter on a VIZAMYL scan. Perform image interpretation independently of the patient's clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal or examine the striatum for VIZAMYL signal as it is less affected by atrophy. Radiation Risk: VIZAMYL contributes to a patient's long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. ADVERSE REACTIONS The most commonly reported adverse reactions in clinical trials were flushing (2 %), increased blood pressure (2 %), headache (1 %), nausea and dizziness (1 %). Postmarketing experience included anaphylactic reactions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. USE IN SPECIFIC POPULATIONS Pregnancy: There are no available data on VIZAMYL in pregnant woman to evaluate drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. All radiopharmaceuticals, including VIZAMYL, have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation dose. If considering VIZAMYL administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. Lactation: There are no data on the presence of flutemetamol F 18 or metabolites in human milk or its effects on the breastfed infant or milk production. Exposure of VIZAMYL to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VIZAMYL and any potential adverse effects on the breastfed child from VIZAMYL or from the underlying maternal condition. Pediatric Use: The safety and effectiveness of VIZAMYL have not been established pediatric patients. Geriatric Use: No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects. OVERDOSAGE The major risks of overdosage relate predominantly to increased radiation exposure, with long-term risk for neoplasia. In the event of administration of a radiation overdose with VIZAMYL, hydration and frequent urination should be encouraged to minimize radiation exposure to the subject. It is unknown whether or not the flutemetamol is dialyzable. Prior to VIZAMYL administration, please read the full Prescribing Information for additional Important Safety Information. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2 then option 1) or by email at or FDA at 800 FDA 1088 or 1 Collij LE, Bischof GN, Altomare D et al. Quantification Supports Amyloid PET Visual Assessment of Challenging Cases: Results from the AMYPAD Diagnostic and Patient Management Study. J Nucl Med. 2025 Jan 3;66(1):110-116. 2 Collij LE, Salvadó G, Shekari M et al. Visual assessment of [(18)F]flutemetamol PET images can detect early amyloid pathology and grade its extent. Eur J Nucl Med Mol Imaging. 2021 Jul;48(7):2169-2182. 3 Bucci M, Savitcheva I, Farrar G et al, A multisite analysis of the concordance between visual image interpretation and quantitative analysis of [(18)F]flutemetamol amyloid PET images. Eur J Nucl Med Mol Imaging. 2021 Jul;48(7):2183-2199. 4 accessed on June 19, 2025 View source version on Contacts GE HealthCare Media Contact: Emmy ElguizaouiUS Communications Director, PDxGE HealthCare+1 978 243 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
24-06-2025
- Health
- Business Wire
FDA Approves Expanded Indications for GE HealthCare's Vizamyl PET Imaging Agent for Beta Amyloid Detection, Enabling More Precise Care for Alzheimer's Patients
ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for its positron emission tomography (PET) imaging agent Vizamyl TM (flutemetamol F 18 injection) for beta-amyloid detection. The revised label, effective immediately, expands the indications for use, enables quantitative analysis of Vizamyl scans, and removes significant previous limitations such as monitoring patient response to anti-amyloid therapy. Up to now, amyloid diagnostics such as Vizamyl have been used to provide a visual assessment of amyloid plaque accumulation in the brain. With quantification now added to the label, clinicians can reach a more objective assessment, using software that enables a calculation of amyloid load, with published research demonstrating that quantification improves diagnostic confidence and consistency among readers 1,2,3. In addition, with the removal of a limitation of use for monitoring therapy effectiveness, Vizamyl can also now be used to assess whether the level of amyloid plaques has been reduced sufficiently for the therapy to potentially be stopped. 'The inclusion of quantification and removal of the therapy monitoring limitation from the Vizamyl label is good news for healthcare providers and their patients, further enabling timely and appropriate care decisions,' said Jit Saini, MD, Chief Medical Officer of the Pharmaceutical Diagnostics (PDx) division of GE HealthCare. 'These changes pave the way for clinicians to expand their usage of Vizamyl, with meaningful implications for patients and their families— helping provide clearer answers, earlier diagnoses, and enabling more personalized treatment strategies.' 'The use of quantification in amyloid PET imaging has steadily moved from research to clinical practice, where it can aid in more confident and accurate diagnosis,' said Phillip Kuo, MD, PhD, FACR, Professor of Radiology, Section Chief of Nuclear Medicine and Director Theranostics at City of Hope National Medical Center. 'Now quantification can also play a critical role in initiating and monitoring amyloid-targeted therapy for Alzheimer's disease and determining when it can be discontinued.' The label update also adds an explicit indication for selection of patients eligible for therapy and removes several previous limitations of use, including for the diagnosis of Alzheimer's disease, based on revised criteria from the Alzheimer's Association, indicating that an abnormal amyloid PET scan is sufficient to establish a diagnosis. Furthermore, the label now removes a previous limitation on predicting the cognitive decline or progression to dementia, based on evidence linking amyloid-positive scans to a higher risk of progression from the early mild cognitive impairment phase of Alzheimer's dementia 4. Vizamyl was first approved in 2013 to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment. GE HealthCare offers solutions for quantitative analysis of amyloid PET scans including through its MIM Neuro Software platform which has been recently FDA cleared for centiloid scaling. GE HealthCare's Pharmaceutical Diagnostics division is a global leader in imaging agents used to support around 130 million procedures per year globally, equivalent to four patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology, with an innovative pipeline, all aimed at enabling better informed diagnosis and monitoring for improved therapy decision making and clinical outcomes. Learn more about Vizamyl at GE HealthCare's PDx booth 1029 at the SNMMI 2025 Annual Meeting June 21 – 24 in New Orleans, LA or online here: About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems 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 care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. GE HealthCare is proud to be among 2025 Fortune World's Most Admired Companies™. Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website for more information. The Alzheimer's Association makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Important Safety Information for Vizamyl TM (flutemetamol F18) injection PRODUCT INDICATIONS AND USE VIZAMYL™ (flutemetamol F 18 injection) is indicated for positron-emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing of information of the therapeutic products. CONTRAINDICATIONS VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80. WARNINGS AND PRECAUTIONS Anaphylaxis and Other Serious Hypersensitivity Reactions: Serious hypersensitivity reactions including anaphylaxis, presenting with flushing, dyspnea, and hypotension have been observed within minutes following administration and may occur in patients with no history of exposure to VIZAMYL. Obtain a history of allergy or hypersensitivity reactions. Always have resuscitation equipment and trained personnel immediately available at the time of VIZAMYL administration. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy. VIZAMYL is contraindicated in patients with a history of hypersensitivity to VIZAMYL or polysorbate 80. Risk of Image Misinterpretation and Other Errors: Errors may occur in the estimation of amyloid beta neuritic plaque density during VIZAMYL image interpretation. The use of clinical information in the interpretation of VIZAMYL images has not been evaluation and may lead to an inaccurate assessment. Extensive brain atrophy and motion artifacts that distort the image may limit the ability to distinguish gray and white matter on a VIZAMYL scan. Perform image interpretation independently of the patient's clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal or examine the striatum for VIZAMYL signal as it is less affected by atrophy. Radiation Risk: VIZAMYL contributes to a patient's long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. ADVERSE REACTIONS The most commonly reported adverse reactions in clinical trials were flushing (2 %), increased blood pressure (2 %), headache (1 %), nausea and dizziness (1 %). Postmarketing experience included anaphylactic reactions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. USE IN SPECIFIC POPULATIONS Pregnancy: There are no available data on VIZAMYL in pregnant woman to evaluate drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. All radiopharmaceuticals, including VIZAMYL, have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation dose. If considering VIZAMYL administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. Lactation: There are no data on the presence of flutemetamol F 18 or metabolites in human milk or its effects on the breastfed infant or milk production. Exposure of VIZAMYL to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VIZAMYL and any potential adverse effects on the breastfed child from VIZAMYL or from the underlying maternal condition. Pediatric Use: The safety and effectiveness of VIZAMYL have not been established pediatric patients. Geriatric Use: No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects. OVERDOSAGE The major risks of overdosage relate predominantly to increased radiation exposure, with long-term risk for neoplasia. In the event of administration of a radiation overdose with VIZAMYL, hydration and frequent urination should be encouraged to minimize radiation exposure to the subject. It is unknown whether or not the flutemetamol is dialyzable. Prior to VIZAMYL administration, please read the full Prescribing Information for additional Important Safety Information. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2 then option 1) or by email at or FDA at 800 FDA 1088 or 1 Collij LE, Bischof GN, Altomare D et al. Quantification Supports Amyloid PET Visual Assessment of Challenging Cases: Results from the AMYPAD Diagnostic and Patient Management Study. J Nucl Med. 2025 Jan 3;66(1):110-116. 2 Collij LE, Salvadó G, Shekari M et al. Visual assessment of [(18)F]flutemetamol PET images can detect early amyloid pathology and grade its extent. Eur J Nucl Med Mol Imaging. 2021 Jul;48(7):2169-2182. 3 Bucci M, Savitcheva I, Farrar G et al, A multisite analysis of the concordance between visual image interpretation and quantitative analysis of [(18)F]flutemetamol amyloid PET images. Eur J Nucl Med Mol Imaging. 2021 Jul;48(7):2183-2199. 4
Business Wire
30-05-2025
- Health
- Business Wire
Updated NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) Recommend Use of FES PET Imaging for Lobular Breast Cancer
ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced that the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) for clinicians now recommend considering fluoroestradiol (FES) positron emission tomography (PET) for systemic staging in patients with recurrent or metastatic lobular breast cancer. GE HealthCare's Cerianna™ (fluoroestradiol F18) injection, available in the United States, is the only FDA-approved imaging agent for the detection of estrogen receptor positive (ER+) breast cancer metastases, including lobular breast cancer. The updated NCCN Guidelines ® expand the recommendation for the use of FES PET imaging in ER+ disease. In 2023, FES PET was included in the NCCN Guidelines for systemic staging of recurrent/stage IV ER+ breast cancer. According to the Breast Cancer Research Foundation, 95% of invasive lobular cancer (ILC) tumors are ER+. i ILC is the second most common type of breast cancer in the U.S., accounting for 10-15% of all breast cancers and an estimated 43,000 new cases each year. ii iii iv Lobular tumors typically do not form lumps which makes the cancer harder to detect with self-exams, mammography, ultrasound and magnetic resonance imaging (MRI). ILC can also recur more than a decade v after initial diagnosis and metastasize to unusual places such as the bones, brain, liver, lungs, gynecological organs, and others. vivii Once recurrent or metastatic lobular breast cancer is suspected, the new guidelines recommend considering FES PET imaging of the whole body to assess whether ER+ lobular tumors are present. 'Lobular cancers are often missed during routine screening, which can result in larger, more advanced tumors when they are finally detected and diagnosed,' said Jit Saini, MD, Chief Medical Officer of the Pharmaceutical Diagnostics (PDx) division of GE HealthCare. 'This NCCN Guidelines update is significant because it will give more oncologists the confidence to use Cerianna PET imaging for patients with lobular breast cancer. It may also facilitate broader insurance coverage so more patients with this common, but hard-to-detect cancer will have an opportunity to receive a comprehensive diagnosis that accelerates clinical decisions and early intervention.' Cerianna is a molecular imaging agent indicated for use with PET imaging for the detection of ER+ lesions as an adjunct to biopsy in patients with known or suspected recurrent or metastatic breast cancer. Cerianna works by binding to functional ER lesions and then the whole body is imaged by PET scan to help doctors assess and treat lobular breast cancer appropriately. With its diffuse growth patterns, detection and biopsy of ILC can be more difficult. Cerianna provides an alternative method to assess ER status across the whole body. The recommendation that FES PET may be appropriate in lobular histology was established by an expert working group convened by the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and included breast care specialists from the SNMMI, Lobular Breast Cancer Alliance, American College of Nuclear Medicine and Korean Society of Nuclear Medicine. The SNMMI is a nonprofit organization that promotes the science, technology and practical application of nuclear medicine and molecular imaging. The National Comprehensive Cancer Network (NCCN ®) is a not-for-profit alliance of 33 leading U.S. cancer centers devoted to patient care, research, and education. The NCCN Guidelines are the recognized standard for clinical direction and policy in cancer care and the most thorough and frequently updated clinical practice guidelines available in any area of medicine. GE HealthCare's Pharmaceutical Diagnostics segment is a global leader in imaging agents used to support around 130 million procedures per year globally, equivalent to four patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology, with an innovative pipeline, all aimed at enabling better informed diagnosis and monitoring for improved therapy decision making and clinical outcomes. Learn more about Cerianna here: About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems 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 care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. GE HealthCare is proud to be among 2025 Fortune World's Most Admired Companies™. Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website for more information. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. IMPORTANT SAFETY INFORMATION FOR CERIANNA™ (FLUORESTRADIOL F18) INJECTION 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). Important Safety Information CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Risk of Misdiagnosis Inadequate Tumor Characterization and Other ER-Positive Pathology Breast cancer may be heterogeneous within patients and across time. CERIANNA images ER and is not useful for imaging other receptors such as HER2 and PR. The uptake of fluoroestradiol F 18 is not specific for breast cancer and may occur in a variety of ER-positive tumors that arise outside of the breast, including from the uterus and ovaries. Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer. False Negative CERIANNA Scan A negative CERIANNA scan does not rule out ER-positive breast cancer. Pathology or clinical characteristics that suggest a patient may benefit from systemic hormone therapy should take precedence over a discordant negative CERIANNA scan. Radiation Risks Diagnostic radiopharmaceuticals, including CERIANNA, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe drug handling and patient preparation procedures (including adequate hydration and voiding) to protect patients and health care providers from unintentional radiation exposure. Pregnancy Status Assessment of pregnancy status is recommended in females of reproductive potential before administering CERIANNA. ADVERSE REACTIONS In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary All radiopharmaceuticals, including CERIANNA, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. Advise a pregnant woman of the potential risks of fetal exposure to radiation from administration of CERIANNA. There are no available data on CERIANNA use in pregnant women. No animal reproduction studies using fluoroestradiol F 18 have been conducted to evaluate its effect on female reproduction and embryo-fetal development. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Lactation Risk Summary There are no data on the presence of fluoroestradiol F 18 in human milk, or its effects on the breastfed infant or milk production. Lactation studies have not been conducted in animals. Advise a lactating woman to avoid breastfeeding for 4 hours after CERIANNA administration in order to minimize radiation exposure to a breastfed infant. Pediatric Use The safety and effectiveness of CERIANNA in pediatric patients have not been established. Geriatric Use Clinical studies of fluoroestradiol F 18 injection did not reveal any difference in pharmacokinetics or biodistribution in patients aged 65 and over. DRUG INTERACTIONS Systemic Endocrine Therapies that Bind to ER Drugs that bind to the ER, including SERMs and SERDs, may compete with the binding of fluoroestradiol F18 and may reduce detection of ER-positive lesions with CERIANNA. Before administration of CERIANNA, discontinue drugs that bind to the ER, such as SERMs and SERDs, for at least 5 biological half-lives: (e.g. elacestrant for 11 days, tamoxifen for 8 weeks and fulvestrant for 28 weeks). Prior to Cerianna administration, please read the full Prescribing Information and additional Important Safety Information here. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2 then option 1) or by email at or FDA at 800 FDA 1088 or JB11825US 2025
Yahoo
30-05-2025
- Business
- Yahoo
Updated NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Recommend Use of FES PET Imaging for Lobular Breast Cancer
NCCN Guidelines® recommend FES PET for systemic staging in certain patients with invasive lobular cancer (ILC), which could facilitate greater diagnostic accuracy, earlier interventions, better clinical decision-making and broader insurance coverage for breast cancer patients. GE HealthCare's Cerianna (fluoroestradiol F18) injection is the first and only U.S. Food and Drug Administration (FDA) approved imaging agent to help clinicians assess estrogen receptor positive (ER+) lesion status in recurrent or metastatic breast cancer. ARLINGTON HEIGHTS, Ill., May 30, 2025--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced that the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for clinicians now recommend considering fluoroestradiol (FES) positron emission tomography (PET) for systemic staging in patients with recurrent or metastatic lobular breast cancer. GE HealthCare's Cerianna™ (fluoroestradiol F18) injection, available in the United States, is the only FDA-approved imaging agent for the detection of estrogen receptor positive (ER+) breast cancer metastases, including lobular breast cancer. The updated NCCN Guidelines® expand the recommendation for the use of FES PET imaging in ER+ disease. In 2023, FES PET was included in the NCCN Guidelines for systemic staging of recurrent/stage IV ER+ breast cancer. According to the Breast Cancer Research Foundation, 95% of invasive lobular cancer (ILC) tumors are ER+.i ILC is the second most common type of breast cancer in the U.S., accounting for 10-15% of all breast cancers and an estimated 43,000 new cases each iii iv Lobular tumors typically do not form lumps which makes the cancer harder to detect with self-exams, mammography, ultrasound and magnetic resonance imaging (MRI). ILC can also recur more than a decadev after initial diagnosis and metastasize to unusual places such as the bones, brain, liver, lungs, gynecological organs, and Once recurrent or metastatic lobular breast cancer is suspected, the new guidelines recommend considering FES PET imaging of the whole body to assess whether ER+ lobular tumors are present. "Lobular cancers are often missed during routine screening, which can result in larger, more advanced tumors when they are finally detected and diagnosed," said Jit Saini, MD, Chief Medical Officer of the Pharmaceutical Diagnostics (PDx) division of GE HealthCare. "This NCCN Guidelines update is significant because it will give more oncologists the confidence to use Cerianna PET imaging for patients with lobular breast cancer. It may also facilitate broader insurance coverage so more patients with this common, but hard-to-detect cancer will have an opportunity to receive a comprehensive diagnosis that accelerates clinical decisions and early intervention." Cerianna is a molecular imaging agent indicated for use with PET imaging for the detection of ER+ lesions as an adjunct to biopsy in patients with known or suspected recurrent or metastatic breast cancer. Cerianna works by binding to functional ER lesions and then the whole body is imaged by PET scan to help doctors assess and treat lobular breast cancer appropriately. With its diffuse growth patterns, detection and biopsy of ILC can be more difficult. Cerianna provides an alternative method to assess ER status across the whole body. The recommendation that FES PET may be appropriate in lobular histology was established by an expert working group convened by the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and included breast care specialists from the SNMMI, Lobular Breast Cancer Alliance, American College of Nuclear Medicine and Korean Society of Nuclear Medicine. The SNMMI is a nonprofit organization that promotes the science, technology and practical application of nuclear medicine and molecular imaging. The National Comprehensive Cancer Network (NCCN®) is a not-for-profit alliance of 33 leading U.S. cancer centers devoted to patient care, research, and education. The NCCN Guidelines are the recognized standard for clinical direction and policy in cancer care and the most thorough and frequently updated clinical practice guidelines available in any area of medicine. GE HealthCare's Pharmaceutical Diagnostics segment is a global leader in imaging agents used to support around 130 million procedures per year globally, equivalent to four patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology, with an innovative pipeline, all aimed at enabling better informed diagnosis and monitoring for improved therapy decision making and clinical outcomes. Learn more about Cerianna here: About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems 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 care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. GE HealthCare is proud to be among 2025 Fortune World's Most Admired Companies™. Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website for more information. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. IMPORTANT SAFETY INFORMATION FOR CERIANNA™ (FLUORESTRADIOL F18) INJECTION 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). Important Safety Information CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Risk of Misdiagnosis Inadequate Tumor Characterization and Other ER-Positive Pathology Breast cancer may be heterogeneous within patients and across time. CERIANNA images ER and is not useful for imaging other receptors such as HER2 and PR. The uptake of fluoroestradiol F 18 is not specific for breast cancer and may occur in a variety of ER-positive tumors that arise outside of the breast, including from the uterus and ovaries. Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer. False Negative CERIANNA Scan A negative CERIANNA scan does not rule out ER-positive breast cancer. Pathology or clinical characteristics that suggest a patient may benefit from systemic hormone therapy should take precedence over a discordant negative CERIANNA scan. Radiation Risks Diagnostic radiopharmaceuticals, including CERIANNA, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe drug handling and patient preparation procedures (including adequate hydration and voiding) to protect patients and health care providers from unintentional radiation exposure. Pregnancy Status Assessment of pregnancy status is recommended in females of reproductive potential before administering CERIANNA. ADVERSE REACTIONS In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary All radiopharmaceuticals, including CERIANNA, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. Advise a pregnant woman of the potential risks of fetal exposure to radiation from administration of CERIANNA. There are no available data on CERIANNA use in pregnant women. No animal reproduction studies using fluoroestradiol F 18 have been conducted to evaluate its effect on female reproduction and embryo-fetal development. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Lactation Risk Summary There are no data on the presence of fluoroestradiol F 18 in human milk, or its effects on the breastfed infant or milk production. Lactation studies have not been conducted in animals. Advise a lactating woman to avoid breastfeeding for 4 hours after CERIANNA administration in order to minimize radiation exposure to a breastfed infant. Pediatric Use The safety and effectiveness of CERIANNA in pediatric patients have not been established. Geriatric Use Clinical studies of fluoroestradiol F 18 injection did not reveal any difference in pharmacokinetics or biodistribution in patients aged 65 and over. DRUG INTERACTIONS Systemic Endocrine Therapies that Bind to ER Drugs that bind to the ER, including SERMs and SERDs, may compete with the binding of fluoroestradiol F18 and may reduce detection of ER-positive lesions with CERIANNA. Before administration of CERIANNA, discontinue drugs that bind to the ER, such as SERMs and SERDs, for at least 5 biological half-lives: (e.g. elacestrant for 11 days, tamoxifen for 8 weeks and fulvestrant for 28 weeks). Prior to Cerianna administration, please read the full Prescribing Information and additional Important Safety Information here. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2 then option 1) or by email at or FDA at 800 FDA 1088 or ______________________________ i Rubio M, et al. Invasive lobular carcinoma: symptoms, treatment, research. Breast Cancer Res. 2025 May 20. Available from: ii McCart Reed AE, et al. Invasive lobular carcinoma of the breast: the increasing importance of this special subtype. Breast Cancer Res. 2021 Jan 7;23(1):6. PMID: 33413533 iii Ciriello G, et al. Comprehensive Molecular Portraits of Invasive Lobular Breast Cancer. Cell. 2015 Oct 8;163(2):506-19. PMID: 26451490 iv 2021 Projected Incidence from ACS Surveillance Research (Source: SEER data) v Pestalozzi BC, et al. International Breast Cancer Study Group. Distinct clinical and prognostic features of infiltrating lobular carcinoma of the breast: combined results of 15 International Breast Cancer Study Group clinical trials. J Clin Oncol. 2008 Jun 20;26(18):3006-14. PMID: 18458044 vi Franzoi MA, et al. Leptomeningeal carcinomatosis in patients with breast cancer. Crit Rev Oncol Hematol. 2019 Mar;135:85-94. PMID: 30819451 vii Blohmer M, et al. Patient treatment and outcome after breast cancer orbital and periorbital metastases: a comprehensive case series including analysis of lobular versus ductal tumor histology. Breast Cancer Res. 2020 Jun 26;22(1):70. PMID: 32586354 JB11825US 2025 View source version on Contacts GE HealthCare Media Contact: Emmy ElguizaouiCommunications Director – Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
