Blue Earth Diagnostics and Siemens' PETNET Solutions announced today that the new fluciclovine F-18 PET imaging agent, Axumin, is commercially available in the U.S. The agent is for recurrent prostate cancer imaging and is the first of its kind.

"This is pretty big news for the PET industry because we have been talking about new tracers coming along for years and years, and we haven't seen that many come to fruition," Barry Scott, head of PETNET, told HCB News.

Prostate cancer recurrence is detected by an increase in prostate specific antigen (PSA) level after initial therapy. Axumin, which received FDA approval in late May, may help to identify the location and extent of the recurrence.

Blue Earth Diagnostics owns the rights to Axumin, but it chose PETNET to also distribute the imaging agent. The initial production of Axumin will be underway at certain PETNET radiopharmacies, but it's expected to be more widely available in the next few months.

"One of the reasons [Blue Earth Diagnostics] chose us among others is that we can reach the vast majority of patients in the U.S., said Scott. "As it becomes more available over the next year or two, we can make sure there are plenty of patients who have access to this interesting tracer."

According to PETNET, it has the largest PET radiopharmaceutical network in the U.S., with about 42 sites around the country.

At the upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI), the companies are expecting there to be an "enormous amount of interest" in Axumin. Other than the fact that it's a new oncology imaging agent, it's also of interest because it's for prostate cancer.

Prostate cancer is currently an unmet need and it's an exciting new growth area, said Scott. CT and MR are usually used to detect prostate cancer recurrence, but there are many challenges with those approaches.

Another benefit of Axumin is that it can be distributed further than other imaging agents. It has the same 110-minute half life as FDG, which can be flown from Seattle, Washington to Alaska.

"One of the reasons [the industry is] excited about it aside from being a new oncology tracer, is the fact that it's in the area of prostate. Prostate imaging is a new growth area in the PET industry, and serves an unmet need," said Scott.

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