In an interview with nine academic sites from its Gallium Users Group, SNMMI found that seven possessed a total of 11 generators, with none at the other two due to lack of availability and waiting times.

Of the seven that did have at least one, six experienced delays in replacement with one still waiting after two months and another after six. Three recently received one each after waiting between two and six months, while four canceled or rescheduled scans and clinical trials. One site, Washington University St. Louis, even cut down dose production from 14 to six or less weekly and instituted a two-week blackout during which none were available to its six area hospitals.


The signatories propose a temporary exemption to the 400-elution limit almost immediately, and for the deployment of the IRE ELiT’s generator, for which a type II drug master file has been submitted to the FDA. They also call for the use of cyclotron-generated gallium with an acqueous target, claiming such actions would increase production at mostly academic sites for the next three to six months and alleviate the need for a GMP-grade generator in particular locations.

Zimmermann agrees that such tactics may help, but warns that the predicament associated with Ge-68/Ga-68 generator production is a complex one that will require more actions; and for Novartis, which owns the rights to NETSPOT, to adjust its protocols around the commercialization of 68Ga to help address the short supply of generators.

“The industry (Novartis) will have to adapt the sales of their therapeutics to the diagnostic agent availability as it is directly linked,” he said. “It will also impact the development of other advanced therapeutics, such as 177Lu-PSMA-617, which rely on 68Ga for the selection of their patients.”

NETSPOT and Lutathera (177Lu-PSMA-617) are produced by AAA, a subsidiary of Novartis.

Letter signatories include Cathy S. Cutler, SNMMI director of the medical isotope research and production program (MIRP) collider-accelerator department at Brookhaven National Laboratory; and SNMMI President Satoshi Minoshima, chair of the department of radiology and imaging sciences at the University of Utah.

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