Eckert & Ziegler Receives Approval for Gallium-68 Generator for Brazil
Eckert & Ziegler Radiopharma GmbH has received approval for its pharmaceutical 68Ge/68Ga generator GalliaPharm(R) from the Brazilian health authority ANVISA. GalliaPharm(R) is thus the first and currently the only pharmaceutical gallium generator approved in Brazil.
“The approval strengthens our market position in Brazil and marks another milestone in our expansion strategy”, explains Dr. Lutz Helmke, Executive Director of Eckert & Ziegler AG and responsible for the Medical segment. “Since there are currently many clinical studies with so-called theranostics worldwide, we expect an increasing demand for both the diagnostic radioisotope gallium-68 and the therapeutic radioisotope lutetium-177 in the next few years”.
GalliaPharm(R) is already successfully used in combination with approved kits, for the diagnosis of neuroendocrine tumors and in clinical trials also for prostate cancer (Ga-68-PSMA kit).
In Brazil, more than 590.000 new cases of cancer have been reported in 2020, with 97.278 in prostate, followed by breast (88.492) and colorectum cancer (55.102). (Source: IARC Global Cancer Observatory, 2020).
Gallium generators offer a low-cost alternative to radioactive labeling of biomolecules with gallium-68 in PET, an imaging examination method used to detect the presence or absence of diseased tissue. The procedure is used primarily in the diagnosis of cancer, heart attacks or neurological diseases. Up to now, the radioisotopes fluorine-18 or carbon-11 have mostly been used to label biomolecules. This requires millions of dollars of investment in large-scale equipment (cyclotrons). The 68Ge/68Ga generator, on the other hand, is about the size of a thermos flask and can be obtained much more cheaply, which reduces costs and increases flexibility in nuclear medical clinics and practices.