Flyrcado, a radioactive diagnostic drug, has been approved to evaluate myocardial ischemia and infarction in adults with known or suspected coronary artery disease.
CI’s Three Key Takeaways:
- FDA approval of Flyrcado: The US Food and Drug Administration has approved Flyrcado (flurpiridaz F 18), a new radioactive diagnostic drug for PET imaging. It’s designed to evaluate myocardial ischemia and infarction in adults with known or suspected coronary artery disease.
- Prevalence and impact of coronary artery disease: Coronary artery disease is extremely common, affecting over 18 million adults in the US. It’s the leading cause of death in the country, with someone having a heart attack approximately every 40 seconds.
- Effectiveness and safety profile: Two clinical studies demonstrated Flyrcado’s effectiveness in detecting significant coronary artery disease, with sensitivity ranging from 63% to 89% and specificity from 53% to 86% across different readers. The most common side effects included shortness of breath, headache, and chest pain.
The US Food and Drug Administration has approved Flyrcado (flurpiridaz F 18, GE HealthCare) in adult patients with known or suspected coronary artery disease to evaluate for myocardial ischemia (cardiac function disorder when the heart muscle doesn’t receive enough blood flow to function properly) and infarction (heart attack).
Flyrcado is a cyclotron-produced radioactive diagnostic drug for positron emission tomography (PET) myocardial perfusion imaging under rest or stress (pharmacologic or exercise). Flyrcado is administered by intravenous injection.
Coronary artery disease is the narrowing or blockage of the coronary arteries, which supply oxygen-rich blood to the heart. It is often caused by plaque buildup in these arteries. Coronary artery disease is very common, impacting over 18 million adults in the US, and is the leading cause of death in the US.
Myocardial ischemia occurs when blood flow to the heart is reduced, often caused by partial or complete blockage of the coronary arteries. Myocardial ischemia reduces the heart’s ability to pump blood. A sudden blockage of one of the coronary arteries can lead to a heart attack. Approximately every 40 seconds, someone in the US will have a heart attack.
Effectiveness
The efficacy and safety of Flyrcado were evaluated in two prospective, multicenter, open-label clinical studies in adults with either suspected coronary artery disease or known or suspected coronary artery disease.
Study 1 evaluated the sensitivity (ability to designate an imaged patient with disease as positive) and specificity (ability to designate an imaged patient without disease as negative) of Flyrcado for the detection of significant coronary artery disease in subjects with suspected coronary artery disease who were scheduled for invasive coronary angiography (ICA). Across three Flyrcado imaging readers, estimates of sensitivity ranged from 74% to 89%, and estimates of specificity ranged from 53% to 70% for CAD defined as at least 50% narrowing of an artery.
Study 2 evaluated the sensitivity and specificity of Flyrcado for the detection of significant coronary artery disease in subjects with known or suspected CAD who had ICA without intervention within 60 days prior to imaging or were scheduled for ICA. Across three Flyrcado imaging readers, estimates of sensitivity ranged from 63% to 77%, and estimates of specificity ranged from 66% to 86% for CAD defined as at least 50% narrowing of an artery.
“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 MPI, 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,” says 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, in a release. “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.”
Safety Information
The most common adverse reactions (occurring in at least 2% of participants receiving Flyrcado for rest and stress imaging) were dyspnea (shortness of breath), headache, angina pectoris (severe pain in the chest), chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia (irregular heartbeat).
Exercise or pharmacologic stress itself is associated with risk of serious adverse reactions, including myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Healthcare professionals should 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, healthcare professionals should perform the procedure in accordance with the pharmacologic stress agent’s prescribing information.
Flyrcado will be available in initial U.S. markets in early 2025 with expanding availability thereafter.
Photo caption: Healthcare professionals reviewing myocardial perfusion PET images.
Photo: Business Wire
