Blue Earth Diagnostics and Siemens’ PETNET Solutions have announced the increasing number of radiopharmacies offering Blue Earth Diagnostics’ Axumin (fluciclovine F 18) PET imaging agent through PETNET’s national network.
In June 2016, PETNET Solutions began exclusive commercial production and distribution of Axumin at 2 sites in the United States, and additional sites have been rolled out in subsequent months.
There are now 12 metropolitan locations in the United States offering Axumin, including the recent addition of sites in Phoenix, Az. and Ft. Lauderdale, Fla., with more sites planned during 2017.
Axumin is a novel molecular imaging agent indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen (PSA) following prior treatment. It is the first FDA-approved F-18 PET imaging agent indicated for use in patients with suspected recurrent prostate cancer.
“Our commitment to increasing the availability of Axumin 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 Ltd.
“In addition to the scheduled radiopharmacy roll-out, Axumin reader training is available in collaboration with the Society of Nuclear Medicine and Molecular Imaging (SNMMI), and this recently included a live training event at its Mid-Winter Meeting.
“We are also very pleased that CMS has granted Axumin transitional pass-through payment reimbursement status using a product-specific HCPCS A code (A9588), which became effective January 1, 2017. In conjunction with our exclusive U.S. commercial manufacturer and distributor, PETNET Solutions, we intend to continue expansion of available radiopharmacies in the coming months so that physicians and patients may have more convenient geographic access to the product.
“Any physician or patient seeking information about where Axumin procedures are offered should call our Medical Information line at 1-855 AXUMIN1 (298-6461); Option 3.”
“We are proud to expand the production and distribution of Axumin, increasing the availability of this important imaging agent to patients in the United States,” said Barry Scott, head of PETNET Solutions.
“Through our broad network of radiopharmacies we are able to increase access to PET tracers, like Axumin, helping healthcare providers to address society’s most challenging diseases.
“Pending U.S. Food and Drug Administration site inspections and approvals, production of Axumin is anticipated to begin at additional PETNET Solutions facilities during 2017, with appropriate locations currently being evaluated to further increase geographic access to the product. We are proud to work with Blue Earth Diagnostics as the exclusive U.S. commercial supplier making Axumin available to imaging centers and their patients.”
Prostate cancer is the second leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients.
Recurrent disease is typically detected by a rise in PSA levels, but often the location and extent of the disease cannot be detected by conventional imaging. Of those patients who experience biochemical recurrence, approximately one-third go on to develop metastatic prostate cancer.