OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a molecular imaging diagnostics company, announced today that the European Commission has granted marketing authorisation for Axumin™ (fluciclovine (18F)) 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. Axumin is 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.
Dr. Jonathan Allis, CEO of Blue Earth Diagnostics, said, “We are delighted by the European Commission’s marketing authorisation for Axumin, which is a major milestone for Blue Earth Diagnostics and underlines our commitment to develop innovative molecular imaging agents that inform and guide treatment decisions for physicians and their patients. Axumin is our first approved product in Europe and we believe that it will benefit men with biochemically recurrent prostate cancer. We are now in discussions with potential manufacturing and distribution associates to make Axumin commercially available across Europe.”
Prostate cancer is the most common cancer in Europe for men, with around 343,000 new cases diagnosed each year1. 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. Axumin 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 visualized in the body with PET imaging.
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Initially, Axumin will be commercially available in Europe in Norway, with roll-out to additional countries planned in 2018.
The Marketing Authorisation Application for Axumin was submitted to the EMA in December 2015 and was approved on 22 May 2017.
1.
http://eco.iarc.fr/EUCAN/CancerOne.aspx?Cancer=29&Gender=1
ABOUT AXUMINTM (FLUCICLOVINE (18F))
Axumin (fluciclovine (18F)) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labelled with the radioisotope (18F) for PET imaging. Fluciclovine (18F) was invented at Emory University in Atlanta, Ga., USA, with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare.
