- 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)
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 women1.
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Healthcare professionals reviewing
myocardial perfusion PET images. (Photo: Business Wire)
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 MPI2, 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 20214. 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 https://www.gehealthcare.com/
for more information.
https://www.gehealthcare.com/products/molecular-imaging-agents/flyrcado
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
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.
Temporarily discontinue breastfeeding. A lactating woman should
pump and discard breastmilk for at least 8 hours after FLYRCADO
administration.
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 www.fda.gov/medwatch
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
www.fda.gov/medwatch.
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.
https://doi.org/10.2967/jnumed.120.246280
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.
https://doi.org/10.1161/CIR.0000000000001123.
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. https://doi.org/10.1016/j.ebiom.2023.104930
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240927874133/en/
GE HealthCare Media Contact: Emmy Elguizaoui +1 (978)
243-7503 Emmy.Elguizaoui@gehealthcare.com
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