Blue Earth gets EMA nod for prostate cancer imaging agent

The offices of the European Medicines Agency

The European Medicines Agency (EMA) has recommended the approval of Blue Earth Diagnostics’ positron emission tomography (PET) imaging agent. EMA’s support positions Blue Earth to become the first firm to get European Union-wide approval for a PET imaging agent for recurrent prostate cancer.

Blue Earth developed the imaging agent, branded Axumin, to provide physicians with a better tool for diagnosing recurrent prostate cancer. Some recurrences are detectable through rises in levels of prostate specific antigen (PSA) but impossible to locate using conventional imaging. This leaves physicians suspecting the cancer has recurred but lacking the information they need to come up with a treatment plan.

Axumin, a synthetic L-leucine analogue radiolabeled with fluorine 18, is designed to overcome this shortcoming. The diagnostic radiopharmaceutical enters cells via amino acid transporters. Tumor cells have enhanced amino acid transport to help them access the materials they need to grow and spread. As such, Blue Earth thought tumors would take up Axumin more than healthy tissues, a hypothesis subsequently backed up by PET imaging studies.

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FDA approved the imaging agent last year on the strength of two studies. One trial compared 105 scans taken using Axumin to results generated through biopsies. Most of the biopsies confirmed the imaging results, although some of the scans were revealed to be false positives. The risk of false positives was particularly high in patients with PSA levels of 1 ng/mL or less.

EMA’s Committee for Medicinal Products for Human Use saw the data presented by Blue Earth as strong enough to justify a recommendation for approval. In response, Blue Earth has begun talking to its manufacturing and distribution partners to get ready to introduce the product in Europe.

That will tee up Blue Earth to begin delivering in Europe on the potential that prompted Syncona Partners to invest $16 million in the company in 2014. The then newly-formed company had spun off from GE Healthcare with the imaging agent that went on to be called Axumin.