The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending that fluciclovine (18F) is granted marketing authorization in the European Union.
The recommendation is for fluciclovine use in Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.
The CHMP’s positive opinion will now be reviewed by the European Commission.
If approved, fluciclovine will be the first and only PET imaging agent indicated for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway.
Prostate cancer is the most common cancer in Europe for men, with around 343,000 new cases diagnosed each year.
While most primary prostate cancer can be successfully treated, the disease recurs in up to one-third of patients.
In some patients, recurrent disease is detectable only by a rise in PSA levels, but often the location of the recurrence cannot consistently be located by conventional imaging, limiting treatment guidance.
Fluciclovine was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer.
It is labelled with the radioisotope (18F), enabling it to be visualised in the body with PET imaging.
The molecule is being investigated by its developers, Blue Earth Diagnostics, for other potential cancer indications, such as glioma.
“The CHMP’s positive recommendation for Axumin (18F) is a major advance in Blue Earth’s commitment to providing a readily available PET imaging agent to detect and localise suspected biochemically recurrent prostate cancer for the thousands of men in Europe affected by this disease,” said Dr. Jonathan Allis, CEO, Blue Earth Diagnostics. “Information provided by a PET scan can help physicians localise disease, which may assist treatment decisions. We now look forward to working with our commercial manufacturing and distribution associates to be ready to make this widely available to doctors and their patients across Europe.”
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