How fast will the U.S. market get access to Gallium-68?

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How fast will the U.S. market get access to Gallium-68?

June 27, 2017
Molecular Imaging PET
From the June 2017 issue of HealthCare Business News magazine

By Richard Zimmermann and Paul-Emmanuel Goethals

The nuclear medicine world is slowly preparing for the introduction of gallium-68-labeled (68Ga) tracers.
The first 68Ga-labeled molecules (68Ga-DOTATATE and 68Ga-DOTATOC) obtained their marketing authorization in the course of 2016, but their use will become more obvious in connection with the associated therapeutic agent, 177Lu-DOTATATE (marketing expected in 2017). A series of new 68Ga tracers, in particular for imaging metastasized prostate cancer, will soon enter late-stage clinical trials. The manufacturing world needs to prepare for these new products. Nowadays, 68Ga-labeled tracers rely only on 68Ge/68Ga generators and synthesis automates. Both the source of 68Ga and the preparation process are already challenged by new technologies while the market will have to adapt to the growing needs.

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The use of gallium-68 as an alternative to fluorine-18 (18F) in the development of new tracers for positron emission tomography (PET) took off mainly in Europe over the past years. Although in absence of tracers with marketing authorization, the routine use of 68Ga tracers was therefore mainly adapted to the European way to get access to radiopharmaceuticals. Most of the nuclear physicians are not aware that the industry providing radiopharmaceuticals is structured in a completely different way in the U.S. compared to Europe.

In Europe, and most countries other than the U.S., each hospital has developed an access to a dedicated preparation room which is equipped with a hot cell that is generally operated by technologists under the control of the hospital pharmacy. This department is preparing the final doses from cold kits and generators, while only long half-life tracers and fluorinated tracers are delivered from central places. Such an infrastructure can, without difficulty, adapt to 68Ge/68Ga generators.

However, when considering the current use of 68Ga, especially using synthesis automates, this local hospital radiopharmacy structure remains expensive as it requires a proportionally high number of dedicated experts (radiochemist, radiopharmacist), local investment as well as local handling authorizations which are still only accessible for a limited number of the hospitals (<25% in Europe). The recent introduction of cold kits, allowing the production of 68Ga tracers as easily as with technetium-99m (99mTc), will definitely reduce the time of preparation and the overall cost for 68Ga-tracers. However the presently high price of generators makes this local product interesting only if all doses of gallium can be used daily in patients.

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