Date: 2017-05-22
Type of information: Granting of a Market Authorisation in the EU
Product name: Axumin™
Compound: fluciclovine (18F)
Therapeutic area: Cancer - Oncology - Diagnostic
Action mechanism: amino acid analog/radiopharmaceutical. Fluciclovine (18F) injection ([18F] FACBC or anti1-amino-3-18F-fluorocyclobutane-1-carboxylic acid), is a synthetic amino acid PET imaging agent. It is being developed to improve the detection of certain cancers by over-coming some of the limitations of existing imaging techniques. The transport and metabolism of amino acids is a normal function of all cells, however dys-regulation of amino acid transporter expression and activity has been linked to cancer promoting molecular signalling pathways, such as those mediated by m-tor. Oka et al explored the uptake mechanism of fluciclovine (18F) into prostate cancer cell lines in vitro and found that internalisation was mediated predominantly by system ASC transporters (such as ASCT2) or LAT1, depending on availability of Na+. The uptake of fluciclovine (18F) into preclinical prostate cancer and glioma models has also been explored with promising results.
Company: Blue Earth Diagnostics (UK)
Disease: detection of recurrence of prostate cancer
Latest news:
- • On May 22, 2017, the European Commission has approved Axumin™ as a diagnostic agent for the detection of recurrence of prostate cancer with Positron Emission Tomography (PET) imaging.
- • On March 23, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Axumin™ , intended to be used as a diagnostic agent for the detection of recurrence of prostate cancer with Positron Emission Tomography (PET) imaging. Axumin™ will be available as a solution for injection (1600 MBq/ml and 3200 MBq/ml). The benefits with Axumin™ are its ability to assess with high sensitivity the sites where prostate cancer has reappeared in patients after primary curative treatment of the prostate gland. Axumin is indicated in patients presenting with elevated blood prostate specific antigen (PSA). The most common side effects are dysgeusia, parosmia and injection site reaction.
- • On May 27, 2016, the FDA has approved Axumin™ (fluciclovine F 18) injection, 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. Axumin is the first FDA-approved F18 PET imaging agent indicated for use in patients with suspected recurrent prostate cancer.
- The FDA-approved prescribing information provides summaries from two clinical studies of Axumin™, including an evaluation of Axumin™ images from 105 patients by three independent readers who were unaware of the clinical details of each patient or whether the biopsy of the prostate gland was positive or negative for cancer. On average, a correct image finding was identified in 77% of patients (range: 75%-79%). For cancer outside the region of the prostate, a correct image finding for cancer was identified in an average of 90% of patients (range: 88%- 93%). The results seem to be affected by PSA levels with, in general, lower PSA levels in patients with negative scans than in those with positive scans. In patients with PSA levels ? 1.78 ng/mL, 15 of 25 had a positive scan, with 11 confirmed as positive by histology; 71 of 74 patients with PSA levels > 1.78 ng/mL had a positive scan, of which 58 were confirmed as positive (see full U.S. prescribing information at www.axumin.com).
- Axumin™ will be commercially available through the national radiopharmacy network of our exclusive U.S. commercial manufacturer and distributor, Siemens’ PETNET Solutions. Initial commercial production of Axumin™ is underway at certain regional radiopharmacies, and increasingly broader availability is planned in coming months.
- Both Emory University and inventor Goodman, Professor of Radiology and Imaging Sciences and Director of the Radiopharmaceutical Discovery Lab at Emory, are eligible to receive royalties for this technology.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2016-05-27
UE authorization: 2017-05-22
Favourable opinion UE: 2017-03-23
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
