In December 2020, the FDA announced that a new radioactive diagnostic agent, Gallium 68 (Ga-68) PSMA-11, could be prescribed and administered to patients with suspected prostate cancer metastasis and suspected prostate cancer recurrence.
Ga-68 is being used in nearly 400 investigational trials for both prostate and other types of cancer, according to the journal Applied Radiology. Based on the outcomes of these trials, the demand for Ga-68 is expected to grow significantly.
Cardinal Health and our robust network of radiopharmacies are poised to meet the demand. We have more than 130 nuclear pharmacies across the country; currently, more than 110 of them are licensed to possess Ga-68, and we expect all 130 to be licensed in the coming months. “We will be able to make these essential radiopharmaceuticals available to healthcare providers and the patients they serve across the country,” said Luke Augustine, vice president of business development for Cardinal Health Nuclear & Precision Health Solutions.
Managing the half-life of Ga-68
Any Ga-68 supply chain strategy must account for the radioactive isotope’s relatively short half-life, Augustine explained. (In nuclear medicine, a half-life is the time it takes for half of the radioactive atoms to decay. The half-life of Ga-68 is about 68 minutes, which means that it must be delivered to providers quickly once it has been prepared.)
Our Nuclear & Precision Health Solutions team manages this half-life with proprietary technologies like AccutracTM, which tracks doses as they move from our nuclear pharmacies to sites of care. (Accutrac has a greater than 99% on-time delivery record.) This technology also documents the chain of custody of patient doses and flags any potential delays in delivery, allowing us to monitor all doses and ensure they are delivered as rapidly as possible.
In addition, providers can use NuctracTM, our cloud-native nuclear medicine department management system, to see exactly when their patient doses will arrive, so they can manage their schedule accordingly.
Partnering with Ga-68 generator manufacturers
At the time of FDA approval of the first Ga-68 radiopharmaceutical in 2016, the Germanium-68 (Ge-68) generators needed to prepare Ga-68 radiopharmaceuticals were scarce, which triggered concerns among health systems about supply. (At first, in fact, the entire world relied on a single Ge-68/Ga-68 generator.)
Today, however, there are three approved manufacturers of Ge-68/Ga-68 generators. Cardinal Health is working with one of the manufacturers, Belgium-based IRE, to distribute generators across the United States. The generators from IRE, called Galli Eo®, feature a small, tabletop design and produce Ga-68 quickly. They can be set up in a nuclear pharmacy to prepare and dispense patient-ready unit doses for just-in-time delivery to sites of care.
“With the addition of multiple Ga-68 supply sources, and a continued expansion of FDA-approved Ga-68 diagnostics, Ga-68 shortages are a thing of the past,” Augustine said.
“Healthcare systems in cities and rural areas will have access to this important diagnostic technology.”