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Access to Axumin PET agent grows as U.S. rollout continues

by Thomas Dworetzky, Contributing Reporter | February 08, 2017
Business Affairs Molecular Imaging Rad Oncology
The rollout of Axumin continues – the number of radiopharmacies offering the Blue Earth Diagnostics PET imaging agent through Siemens PETNET’s national network has now reached a dozen.

“Our commitment to increasing the availability of Axumin (Fluciclovine F 18) for patients with biochemically recurrent prostate cancer has been progressing well and according to plan since its FDA approval in May 2016,” said Jonathan Allis, D.Phil., CEO of Blue Earth Diagnostics, in a statement.

PETNET began exclusive commercial production and distribution of Axumin at two sites in the U.S. in June of last year, and now the latest additions include sites in Phoenix, Arizona, and Ft. Lauderdale, Florida.
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Axumin is used to pick up prostate cancer recurrence in patients with elevated PSA levels and is the first FDA-approved F-18 PET imaging agent indicated for that use.

Blue Earth is also working with the Society of Nuclear Medicine and Molecular Imaging (SNMMI) to provide Axumin reader training.

In addition, Axumin has gotten transitional pass-through payment reimbursement status from CMS, starting January, 2017.

“Through our broad network of radiopharmacies we are able to increase access to PET tracers, like Axumin, helping health care providers to address society’s most challenging diseases,” noted Barry Scott, head of Siemens PETNET Solutions.

Up to a third of those with prostate cancer experience a recurrence – and the disease is the second leading cause of death from cancer in men.

While recurrences can be spotted from a rise in blood PSA, locating the exact spot and extent of the problem can be tricky. Those with a recurrence risk a 33 percent chance of metastatic disease.

Axumin's commercial rollout began late last year.

In September, at Atlanta's Northside Hospital, Dr. William C. Lavely, nuclear medicine specialist at Northside Radiology Associates, stated that, "our initial experience is positive, demonstrating abnormal uptake in locations of potential metastatic prostate cancer."

He added that, "in my opinion, this prostate cancer PET agent, its clinical use for the evaluation of recurrent prostate cancer, and the additional information it provides for developing patient management plans, has the potential to lead to better outcomes in men with recurrent prostate cancer."

When the agent officially launched in June, 2016, PETNET's Scott told HCB News: "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."

In late May, 2016, when the FDA gave the nod to Axumin, Dr. Libero Marzella, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research, stated that “imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels,” but, “Axumin is shown to provide another accurate imaging approach for these patients.”

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