FDA approves novel PET radiotracer for evaluation of suspected MI, ischemia
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Key takeaways:
- The FDA approved a novel PET radiotracer for evaluation of possible MI and ischemia.
- The approval is based on prior research demonstrating superiority of 18F flurpiridaz PET vs. SPECT for evaluation of CAD.
The FDA approved 18F flurpiridaz, a new cardiac PET perfusion radiotracer, for adult patients with known or suspected coronary artery disease being evaluated for myocardial ischemia and infarction.
18F flurpiridaz (Flyrcado, GE Healthcare/Lantheus Medical Imaging) is a cyclotron-derived IV injected radiotracer for use in PET myocardial perfusion imaging under rest or stress, according to an FDA press release.
“The flurpiridaz approval by the FDA is another step forward in seeing the growth and evolution of nuclear cardiology. There is a sequential process that takes place as we see new technology, but also supporting resources that are needed for their success,” Lawrence Phillips, MD, FASNC, medical director of outpatient cardiology at NYU Langone Heart and associate professor in the department of medicine in the Leon H. Charney Division of Cardiology at NYU Grossman School of Medicine, told Healio. “With flurpiridaz, on top of the other radiopharmaceuticals we have for PET, it allows many different types of practices and laboratories to move into cardiac PET perfusion, and this is going to have a great impact of our patients’ care.”
The approval is based on two prospective, multicenter, open-label trials in adults with suspected or known CAD.
The first trial, published in the Journal of the American College of Cardiology in 2020, evaluated diagnostic value of 18F flurpiridaz for myocardial blood flow quantification compared with technetium-99m–labeled single photon emission computed tomography SPECT.
In this trial, 18F flurpiridaz demonstrated promise for the clinical measurement of myocardial blood flow.
In the second trial, the phase 3 AURORA trial published in the Journal of the American College of Cardiology in 2022, researchers compared the efficacy of PET plus the novel radiotracer with SPECT for myocardial perfusion imaging.
As Healio previously reported, 18F flurpiridaz PET showed higher sensitivity compared with SPECT for CAD detection (80.3% vs. 68.7; P = .0003) and noninferior specificity (PET, 63.8%; SPECT, 61.7%; P for noninferiority = .0004).
“This approval is going to increase the access and utilization of cardiac PET perfusion. One of the bigger impediments for a small program to start using PET had to do with availability of isotopes,” Phillips told Healio. “With flurpiridaz, the ability to get a single unit dose is going to allow labs that have appropriate but lower volume of patients to get into the area of PET perfusion.
“What we see with flurpiridaz is improvement in myocardial extraction — the amount of isotope that’s taken out of the blood at a particular blood flow — and this allows a better sensitivity to perfusion abnormalities as it relates to blood flow,” he said. “How it’s going to play out long term is an open question. But we expect to see a greater uptick in PET perfusion for the appropriate patients.”
Adverse reactions occurred in approximately 2% of patients who received 18F flurpiridaz PET, the most common of which were dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness and arrhythmia, according to the release.
“I haven’t seen anything to suggest any difference in side effect or problems with flurpiridaz compared with other isotopes,” Phillips said.
The development and testing of 18F flurpiridaz for CAD evaluation has been of clinical interest for some time. In 2014, Jamshid Maddahi, MD, FACC, FASNC, professor of cardiology and nuclear medicine, and René R.S. Packard, MD, assistant professor-in-residence of medicine and physiology at UCLA School of Medicine, wrote a paper published in Seminars in Nuclear Medicine on the potential clinical value compared with other contemporary radiotracers.
They explained that radiotracers such as 15O water, 13N ammonia and 82Rb have half-lives ranging for 1.25 minutes to nearly 10 minutes; however, 18F flurpiridaz has a half-life of approximately 108 minutes.
"The enhanced sensitivity and specificity of PET radiotracers compared to SPECT radiotracers, as well as their inherent attenuation correction and ability to quantitate flow in an absolute manner further increases the value of a PET based approach,” the authors wrote. “The major Achilles heel of routine PET MPI however has been the availability of radiotracers, with current requirement for either onsite or very nearby cyclotrons or costly generators. In this context 18F-based PET radiotracers, taking advantage of the radioisotope's 108-minute half-life, have garnered significant interest and have been developed by academic centers and biotechnology companies."
For more information:
Lawrence Phillips, MD, FASNC, can be reached at 530 First Ave., Skirball 9U, New York, NY 10016.
References:
- Maddahi J, et al. Semin Nucl Med. 2014;doi: 10.1053/j.semnuclmed.2014.06.011.
- Maddahi J, et al. J Am Coll Cardiol. 2020;doi:10.1016/j.jacc.2020.05.063.
- Maddahi J, et al. J Am Coll Cardiol. 2023;doi:10.1016/j.jacc.2023.08.016.
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