In response to the Department of Engery's request for comments on the consideration of withdrawl from the commercial production of Germanium-68, NorCal CarciNet's board submitted the following on behalf the support group.
To submit your own comments please visit the Federal Register website. Comment period ends April 30, 2013.
UPDATE: April 2, 2014. The Department has concluded that it will not withdraw from the market for Ge-68 for the manufacture of generators, however, because it has determined that there are no suppliers of bulk Ge-68 qualified for use in Ge-68/Ga-68 generators.
To read the final rulling please click here.
RE: Comments on Consideration of Withdrawal from Commercial Production and Distribution of the Radioisotope Germanium-68
Dear Dr. Garland,
NorCal CarciNET Support Group, representing over 150 patient and support providers in Northern California who are living with nueroendocrine carcinoma, appreciates the DOE's current production and distribution of Germanium-68 (Ge-68) radioisotope. The Ge-68 is used for the clinical research production of daughter product Gallium-68 (Ga-68), a promising radionuclide currently under evaluation in an increasing number of novel PET imaging agents for imaging cancer, heart disease, and other disorders. In recent years, Ga-68-labeled radio-pharmaceuticals have demonstrated utility for PET imaging of neuroendocrine tumors with several new studies on patients underway in the US.
It is the position of NorCal CarciNET that any interruption in the stable and affordable supply of Ge-68 and the medically important daughter radioisotope Ga-68, could have a detrimental effect on patients with neuroendocrine tumors.
NorCal CarciNETs supports the DOE's incremental withdrawal from the production of Ge-68 radioisotope in parallel with commercial entities meeting production benchmarks, regulatory approvals and production capacities. We also encourage that the DOE's production facilities maintain "standby" production capacities to act as an emergency stopgap supplier in the event commercial suppliers have unanticipated regulatory or technical problems that interrupt critical continuous supply of this radionuclide.
Today the use of Ga-68 for PET/CT imaging of neuroendocrine tumors is the standard of care in Europe and Asia. The US demand is increasing as the clinical evaluation of Ga-68 labeled compounds expands. The need for Ga-68 labeled agents is real, and they fill an unmet clinical need. Patients battling nureoendocrine carcinoma deserve a stable, reliable, and affordable supply of this medically important isotope.