GE HealthCare has received approval from the US Food and Drug Administration (FDA) for Flyrcado (flurpiridaz F 18) injection, a positron emission tomography (PET) radiotracer for enhanced diagnosis of coronary artery disease (CAD).
The Flyrcado PET myocardial perfusion imaging (MPI) agent is indicated for patients with known or suspected CAD.
It is available as a unit dose – or ready-to-use and is claimed to deliver higher diagnostic efficacy compared to SPECT MPI, which is widely used in nuclear cardiology.
The Flyrcado drug has the potential to extend clinician and patient access to PET MPI, as it can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose.
Also, the imaging agent can enhance diagnostic accuracy in difficult-to-image patients like the ones with a high body mass index (BMI) and women, said the company.
In 2017, GE HealthCare acquired exclusive global rights to flurpiridaz F 18 from Lantheus and pursued the funding and development of the product through to approval.
The company intends to commercialise Flyrcado in initial US markets in early 2025.
GE HealthCare pharmaceutical diagnostics (PDx) segment CEO Kevin O’Neill said: “As the first and only FDA-approved F 18 PET MPI radiotracer for CAD detection, Flyrcado can make a real difference to clinicians and their patients.
“This is another example of GE HealthCare’s commitment to innovating and investing to shape the future of molecular imaging, increasing diagnostic confidence and addressing unmet patient needs.”
Flyrcado is the third F18 imaging agent in GE HealthCare’s portfolio of FDA-approved radiopharmaceutical PET imaging agents, joining Cerianna and Vizamyl.
Cerianna is used to detect estrogen receptor-positive lesions as an adjunct to biopsy in patients with metastatic and recurrent breast cancer.
Vizamyl is used for PET imaging the brain to estimate beta-amyloid neuritic plaque density in adult patients who are being evaluated for Alzheimer’s disease or other causes of cognitive decline.
Flyrcado comes with a half-life of 109 minutes, which is longer than existing PET MPI tracers, to eliminate the need for on-site tracer production and generator maintenance.
The longer half-life allows Flyrcado to integrate exercise stress testing with cardiac PET imaging for CAD, facilitating a strong protocol for assessing ischemia in patients.
Also, it allows clinicians to rescan a patient during the same imaging session in the event of technical difficulties, instead of rescheduling an additional scan, said GE HealthCare.
Flyrcado clinical trials principal investigator Jamshid Maddahi said: “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 MPI2, 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.
“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.”
