GE HealthCare's Flyrcado (flurpiridaz F-18) Receives FDA Approval as First and Only F-18 PET MPI Agent for Coronary Artery Disease Detection

GE Healthcare announces that the U.S. Food and Drug Administration (FDA) has approved the positron emission tomography myocardial perfusion imaging (PET MPI) drug Flyrcado (flurpiridaz F 18) injection for the detection of coronary artery disease (CAD).

GE Healthcare stated that, compared to the commonly used Single Photon Emission Computed Tomography (SPECT) MPI in today's nuclear cardiology,Flyrcado is suitable for known or suspected CAD patients, with higher diagnostic efficacy.Flyrcado can be produced in off-site pharmacies and provided in ready-to-use unit doses, potentially expanding clinicians' and patients' access to PET MPI, including improving diagnostic accuracy for difficult-to-image patients, such as those with a high body mass index (BMI) and women.

Flyrcado has a half-life of 109 minutes, much longer than existing PET MPI tracers, eliminating the need for on-site tracer production and generator maintenance, and enabling distribution to a wide network of hospitals and imaging centers.

The company stated that the longer half-life also means that Flyrcado presents the first practical opportunity to combine exercise stress testing with CAD cardiac PET imaging, providing the most robust solution for evaluating ischemia in patients. Additionally, if technical difficulties arise, clinicians will be able to rescan the patient during the same imaging session rather than scheduling an additional scan.

"Fyrcado is the most exciting development in the field of nuclear cardiology in recent decades," said Dr. Jamshid Maddahi, principal investigator of the Fyrcado clinical trial, clinical professor of medicine (cardiology) and molecular and medical pharmacology (nuclear medicine) at the David Geffen School of Medicine at UCLA (Los Angeles, USA), and director of the Biomedical Imaging Institute. "Although PET MPI offers high diagnostic accuracy compared to SPECT MPI2, only a small number of PET MPI procedures are performed in the United States due to the limited availability of currently used PET tracers — a challenge that can be addressed with the introduction of Fyrcado."

Mouaz Al-Mallah, Past President of the American Society of Nuclear Cardiology (ASNC) and Director of Cardiac PET at Houston Methodist Hospital (Houston, USA), said: "I am excited about this new radiotracer and its potential impact because it is a game-changer in diagnosing the world's leading cause of mortality. Given Flyrcado F 18's ideal characteristics in myocardial uptake and F-18 imaging properties, Flyrcado represents an excellent combination of tracer pharmacology and imaging convenience for both institutions and patients. This tracer opens up new possibilities for cardiac PET; it can be ordered in unit doses and offers the flexibility to perform exercise stress tests. We anticipate that new imaging centers will be able to offer cardiac PET, making PET MPI more accessible and providing meaningful benefits for clinicians and their patients."

Kevin O'Neill, CEO of GE HealthCare's Pharmaceutical Diagnostics (PDx) division, stated: "As the first and only F 18 PET MPI radiotracer approved by the FDA for CAD detection, Flyrcado can bring real change to clinicians and their patients. This is another example of GE HealthCare’s commitment to innovation and investment in shaping the future of molecular imaging, enhancing diagnostic confidence, and addressing unmet patient needs."

Flyrcado is set to launch in the preliminary U.S. market in early 2025, with an expanded supply to follow.

This Issue's Planning: Shen Li

Editorial Responsibility: Chen Baolin

Author of this article: Yun Ye Xuan

Post-production:Ling Wujuan