Radiology Matters

Nuclear Medicine Prepares for Greater 68Ga Demand

Mary Beth Massat


Appl Radiol. 2021;50(2):30-31. 

In This Article

Abstract and Introduction


When the US Food and Drug Administration (FDA) approved the use of Gallium-68 prostate-specific membrane antigen (PSMA)-11 (68Ga PSMA-11) PET imaging for prostate cancer in December, nuclear medicine specialists were not the only ones excited by the development.

Several companies aligned with the production and supply chain for 68Ga had been anticipating—and planning for the FDA's approval and its subsequent expected impact on demand for 68Ga, which can be used diagnostically when paired with PSMA-11, and therapeutically when paired with lutetium-177 or actinium -225.

"We made the investment in a GMP 68Ga generator years before any drugs were approved, betting that the market was going to have a 68Ga drug," says Jay Simon, general manager and managing director of Eckert & Ziegler Radiopharma (Berlin).

In its action, the FDA gave the University of California, San Francisco (UCSF) and University of California, San Diego (UCSD) approval to label the 68Ga isotope with PSMA for PET Imaging of the prostate.

Researchers reported that clinical trials comparing PSMA PET imaging with 18F fluciclovine PET found that 68Ga PSMA-11 PET detected significantly more prostate lesions than 18F fluciclovine PET imaging in cases of cancer recurrence following prostatectomy.[1] Peter Carroll, MD, a professor at the UCSF Helen Diller Family Comprehensive Cancer Center, called the development a "game changer" in a statement issued by UCSF.

In addition, there are nearly 400 clinical trials[2] currently underway involving the use of 68Ga for both diagnosis and therapeutics for prostate, neuroendocrine tumors and other types of cancer. "The market is definitely growing, even beyond PSMA," says Lutz Helmke, PhD, Head of the Medical Radiopharma Segment at Eckert & Zeigler. "We believe there are many more tracers that will come to market and, therefore, we have done our utmost to increase capacity for this product."

Dr Helmke adds that after the 2017 shortage of germanium, which is used to make 68Ga, Eckert & Ziegler further increased its generator production capacity. He believes the company can meet current world demand for 68Ga generators; however, he said the company is also preparing for the increase in demand resulting from the anticipated regulatory clearance of 68Ga PSMA-11 for general clinical use and will be looking for additional suppliers for its GMP grade germanium.

Dr Helmke says there is a trend in the US toward developing larger 68Ga generators with higher activities, from 50 mCi to 100 mCi. Eckert & Ziegler has developed a higher activity/higher capacity generator and will be filing for FDA approval in the near future. The company has also opened a new production facility in the Boston area.

"We have a geo strategy to serve our clients regionally but more importantly, we will have CMO capabilities so we can produce our customers final product," Dr Helmke says.