by John R. Fischer
, Senior Reporter | August 21, 2018
SNMMI has three proposals for combating
the Ga-68 generator shortage
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) has proposed three solutions for the shortage of generators used in the production of Gallium-68 throughout the U.S.
In a letter addressed to the FDA, the organization outlined the need for greater production, pointing to the demand for and benefits of GMP-grade germanium-68/gallium-68 generators, used to produce 68Ga for the subsequent production of NETSPOT, a kit for the preparation of gallium 68Ga dotatate injections.
“NETSPOT is currently approved for use only with the GalliaPharm 68Ga generator from Eckert & Ziegler,” said the signatories in their letter. “NETSPOT has experienced rapid adoption in the U.S. Advanced Accelerator Applications (AAA) and has been expanding the network of pharmacies that distribute NETSPOT since its approval. As of June 2018, approximately 500 imaging sites were requesting doses of NETSPOT for their neuroendocrine tumor patients.”
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Since its 2016 approval under E&Z, demand for the somatostatin receptor PET tracer has increased among those treating neuroendocrine tumors (NETs) in adult and pediatric patients, quickly replacing its market predecessor due to its patient-friendly regimen as an injection, reduction of imaging exams to approximately three hours, and its coverage by payors.
The solution is approved for 400 elutions or for use of up to one year, adding to demand with requests for replacements when such marks are reached. The AAA reports that many often hit their elution limit before the end of one year.
Such needs have exacerbated production of Ge-68/Ga-68 generators, leading to waiting periods of between 14 and 18 months. Though planning to expand production with the construction of a new facility, E&Z will not be able to commence manufacturing there until mid-2019.
“The three companies able to sell generators or with generators under development underestimated the volume,” Richard Zimmermann, co-founder and partner of MEDraysintell and founder and senior consultant of nuclear medicine at Chrysalium Consulting SARL, told HCB News. “E&Z needs to build a new facility that itself needs approval from authorities, hence the date of mid-2019 to be ready. IRE has now a generator with MA but due to internal reorganization, has not yet started growing capacity. ITM had a generator for a long time under development that could compensate shortages for at least the next two years, but it still is not approved.”
To conserve generator lifespan, distributors have resorted to self-imposed blackouts for NETSPOT doses, creating insufficient supplies and delays in procedures.