GE HealthCare announced that the U.S. FDA has approved Flyrcado™ (flurpiridaz F 18) injection, a novel PET myocardial perfusion imaging (MPI) agent, for detecting coronary artery disease (CAD). Flyrcado, designed for patients with known or suspected CAD, offers higher diagnostic accuracy compared to SPECT MPI, which is widely used in nuclear cardiology. It is available as a ready-to-use unit dose, improving access to PET MPI for more patients, including those with high body mass index (BMI) and women.
Flyrcado’s 109-minute half-life enables broad distribution to hospitals and imaging centers without requiring on-site tracer production, and it supports exercise stress testing combined with cardiac PET imaging for enhanced ischemia evaluation. Additionally, its longer half-life allows for patient rescans during the same session in case of technical issues.
Dr. Jamshid Maddahi, lead investigator for Flyrcado’s clinical trials, called it a major advancement in nuclear cardiology. He noted that while PET MPI provides high diagnostic accuracy, limited access to current tracers has hindered its widespread use, a gap Flyrcado could fill.
Coronary artery disease, the leading cause of death in the U.S., claimed 695,000 lives in 2021. The Phase III AURORA trial demonstrated Flyrcado’s diagnostic superiority over invasive coronary angiography and SPECT MPI. Around six million MPI procedures are performed annually in the U.S. to evaluate myocardial ischemia or infarction.
Dr. Mouaz Al-Mallah, an expert in cardiac PET, emphasized Flyrcado’s favorable properties and potential to expand cardiac PET access, making it more convenient for clinicians and patients alike.
Kevin O’Neill, CEO of GE HealthCare’s Pharmaceutical Diagnostics segment, highlighted Flyrcado as the first FDA-approved F 18 PET MPI radiotracer for CAD detection. He underscored GE HealthCare’s dedication to advancing molecular imaging and addressing unmet diagnostic needs.
Flyrcado joins GE HealthCare’s portfolio of FDA-approved PET imaging agents, including Cerianna™ (fluoroestradiol F 18) for breast cancer and Vizamyl™ (flutemetamol F 18) for brain imaging in Alzheimer’s evaluations. GE HealthCare acquired global commercialization rights for Flyrcado from Lantheus in 2017 and will collaborate on its commercialization.
Flyrcado is expected to launch in U.S. markets in early 2025, with wider availability to follow.
GE HealthCare is a leader in medical technology and pharmaceutical diagnostics, supporting over 120 million patient procedures globally each year.
