Two years after spinning out of GE Healthcare, Blue Earth Diagnostics has obtained FDA approval for its prostate cancer tracer Axumin. Used to detect recurrent disease, the positron emission tomography (PET) imaging product will go on sale in the US later this year.
If it is unusual for a company to go to the US before Europe, it is even rarer to secure a venture backer with a long-term view. BED is funded by Syncona, the investment group set up by the UK charity the Wellcome Trust, and the company argues that Syncona puts more emphasis on patients’ health and less on getting its money back than some other VCs might. But both organisations still need Axumin to succeed on the market.
Fortunately there is a pretty solid economic argument for Axumin’s use. The cure rates for primary prostate cancer are fairly high, thanks in large part to widespread screening, but recurrent cancer is often more aggressive and it can be hard to locate the actual tumours. Treatment regimens can be expensive as well as unpleasant for the patient.
Theoretically the use of Axumin to locate tumours will enable each patient to receive the right therapy – surgery, radiotherapy, chemo or hormone therapy, for instance. This ought to cut costs even after the relatively expensive PET is factored in.
Isotope so too
That is, if the clinical data can convince oncologists as well as the FDA. According to the FDA, approval of Axumin was based on two trials, both of which showed it safe and effective for imaging prostate cancer in men with elevated levels of prostate-specific antigen following prior treatment.
Details of these trials, however, are scant. The first, blinded, study examined 105 scans using the Axumin tracer in men with suspected recurrent prostate cancer. First, on-site radiologists read the scans and subsequently three independent radiologists read the same scans. Their findings were compared with results from prostate biopsy and from biopsies of suspicious imaged lesions.
On average, a correct image finding was identified in 77% of patients, Blue Earth said. For cancer outside the region of the prostate, a correct image finding was made in 90% of patients.
In the second study the same radiologists evaluated 96 scans, comparing those using Axumin with others using C11 choline, an approved PET tracer. The results of the independent scan readings “were generally consistent with one another”, and confirmed the results of the onsite scan readings, the FDA said.
Clearly this has been enough for the FDA, which will have been working closely with Blue Earth as Axumin, a compound called fluciclovine labelled with a radioactive fluorine isotope, has priority review status. The company will surely need to make more detailed clinical data available to doctors if it wants the tracer to be well received.
Two years old
The product is tricky to make; fluorine-18 decays quite rapidly so must be manufactured fairly close to the hospital at which it is to be used. But Blue Earth believes this will not be a barrier to uptake, and intends continue its push towards getting European approval for the tracer in recurrent prostate cancer. Axumin is also in phase II for imaging of glioma.
US approval is not a bad result for a company only two years old. Blue Earth was spun out of GE Healthcare, from which it licensed the tracer, with a £12.8m ($18.8m) investment from Syncona (Blue Earth Diagnostics “super focused” on GE’s PET tracer, March 18, 2014).
Syncona kicked in another £18m in July 2015. Even if it is less fixated on making a short-term return than many funds, Axumin will still have to sell if either Syncona or Blue Earth is to consider itself a success.