Eckert & Ziegler receives approval for Gallium-68 generator for cost-effective diagnosis of cancer
Eckert & Ziegler Radiopharma GmbH has received approval from the Federal Institute for Drugs and Medical Devices (BfArM) for its pharmaceutical 68Ge/68Ga generator for the German market. The 68Ge/68Ga generator is the world’s first, approved radionuclide generator to use a radionuclide for positron emission tomography (PET) in the diagnosis of cancer. It also meets the strict requirements for pharmacopoeia monographs. Germanium penetration, an essential factor for patient safety, is < 0.001% over its entire one-year shelf life.
Gallium generators provide an inexpensive alternative for radiolabeling biomolecules using PET, an imaging process which can be used to determine whether tissue is diseased. The process is mainly used to diagnose cancer, heart attacks or neurological diseases. Until now, fluorine-18 or carbon-11 radioisotopes have generally been used to radiolabel biomolecules. The radioisotopes are produced using cyclotrons, large-scale installations which require millions in investment. In contrast, the 68Ge/68Ga generator is approximately the size of a thermos and can be sourced much more inexpensively, lowering costs and increasing flexibility at nuclear medicine clinics.
Eckert & Ziegler has submitted its documents for the gallium generator to the U.S. Food and Drug Administration (FDA), establishing a Drug Master File (DMF no. 28741) with the agency. This will allow parties interested in developing new drugs for the U.S. market to refer to the DMF and use the generator in clinical tests for medication and in other settings. Approval for sale in additional European countries has already been granted.
Dr. André Heß, Member of the Executive Board of Eckert & Ziegler AG and Head of the Radiopharma segment, commented: “We are proud to have gotten the ball rolling with the world’s first approval of a pharmaceutical 68Ge/68Ga generator. We would also like to encourage academic research and development departments in the international pharmaceutical industry to introduce more substances into clinical development which can be radiolabeled with 68Ga. “Theranostic” approaches which combine diagnosis using 68Ga PET with treatment using Yttrium-90, coupled using the same carrier molecule, are also very promising.”
Eckert & Ziegler operates a network of cyclotrons in central and eastern Europe and manufactures pharmaceutical Yttrium-90 (EU-approved product: Yttriga). The company has developed a customized technology platform for the local production of radiopharmaceuticals (especially for 68Ga and 90Y-based pharmaceuticals) which allows clinical users to perform all processes, from synthesis and quality control to patient dose preparation.
Note: This press release has been copied from www.ezag.com. Eckert & Ziegler received Gallium-68 generator approval for GalliaPharm®. The trademark is not mentioned in the news as it was not finally registered at the time of the press release.