Healthcare professionals reviewing myocardial perfusion PET images
GE Healthcare gets FDA nod for 'game changer' cardiac PET tracer
October 02, 2024
by Gus Iversen, Editor in Chief
GE HealthCare has received FDA approval for Flyrcado (flurpiridaz F 18), the first FDA-approved F 18 PET myocardial perfusion imaging (MPI) agent for coronary artery disease (CAD) detection, offering higher diagnostic accuracy compared to the more commonly used SPECT agent.
One key advantage of Flyrcado is its 109-minute half-life, which is more than 10x longer than other currently approved cardiac PET radiotracers. This extended half-life allows the radiotracer to be produced off-site and distributed widely to hospitals and imaging centers, removing the need for on-site manufacturing.
The longer half-life also enables the combination of exercise stress-testing with PET imaging, providing clinicians with a more comprehensive tool to evaluate ischemia in patients. Flyrcado can also be delivered as a ready-to-use, unit-dose injection, potentially expanding access to PET MPI for both patients and healthcare providers.
“Flyrcado is the most exciting development in the field of nuclear cardiology over the past few decades,” said Dr. Jamshid Maddahi, principal investigator of Flyrcado’s clinical trials and professor at UCLA School of Medicine, in a statement. Calling the radiotracer a "game changer" he emphasized its potential to increase access to PET MPI, which has been underutilized due to limited availability of PET tracers.
Coronary artery disease, the leading cause of death for both men and women in the U.S., claimed 695,000 lives in 2021. Around six million MPI procedures are performed annually in the U.S. to assess blood flow to the heart and diagnose conditions such as myocardial ischemia. The AURORA Phase III trial compared Flyrcado to invasive coronary angiography, confirming its high diagnostic efficacy.
Flyrcado is part of GE HealthCare’s growing portfolio of molecular imaging products. The company already offers two other F 18 imaging agents — Cerianna for breast cancer detection and Vizamyl for imaging amyloid plaques in Alzheimer’s disease.
GE HealthCare acquired global commercialization rights for flurpiridaz F 18 from Lantheus in 2017 and collaborated with the company on its development.
Flyrcado will be available in the U.S. starting in early 2025, with expanded availability to follow.
One key advantage of Flyrcado is its 109-minute half-life, which is more than 10x longer than other currently approved cardiac PET radiotracers. This extended half-life allows the radiotracer to be produced off-site and distributed widely to hospitals and imaging centers, removing the need for on-site manufacturing.
The longer half-life also enables the combination of exercise stress-testing with PET imaging, providing clinicians with a more comprehensive tool to evaluate ischemia in patients. Flyrcado can also be delivered as a ready-to-use, unit-dose injection, potentially expanding access to PET MPI for both patients and healthcare providers.
“Flyrcado is the most exciting development in the field of nuclear cardiology over the past few decades,” said Dr. Jamshid Maddahi, principal investigator of Flyrcado’s clinical trials and professor at UCLA School of Medicine, in a statement. Calling the radiotracer a "game changer" he emphasized its potential to increase access to PET MPI, which has been underutilized due to limited availability of PET tracers.
Coronary artery disease, the leading cause of death for both men and women in the U.S., claimed 695,000 lives in 2021. Around six million MPI procedures are performed annually in the U.S. to assess blood flow to the heart and diagnose conditions such as myocardial ischemia. The AURORA Phase III trial compared Flyrcado to invasive coronary angiography, confirming its high diagnostic efficacy.
Flyrcado is part of GE HealthCare’s growing portfolio of molecular imaging products. The company already offers two other F 18 imaging agents — Cerianna for breast cancer detection and Vizamyl for imaging amyloid plaques in Alzheimer’s disease.
GE HealthCare acquired global commercialization rights for flurpiridaz F 18 from Lantheus in 2017 and collaborated with the company on its development.
Flyrcado will be available in the U.S. starting in early 2025, with expanded availability to follow.