AXUMIN (18F-Fluciclovine), radiopharmaceutical
DIAGNOSTIC - New medicinal product
Opinions on drugs -
Posted on
Oct 24 2018
Reason for request
Inclusion
High clinical benefit in the detection of prostate cancer recurrence in the event of suspected recurrence after first-line treatment, though no demonstrated clinical added value in the therapeutic strategy.
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AXUMIN has been granted marketing authorisation for positron emission tomography (PET) imaging to detect recurrent prostate cancer in the event of suspected recurrence based on a renewed increase in serum prostate-specific antigen (PSA) concentrations after first-line curative treatment.
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The poor methodological quality of the data available, along with the lack of comparison to 18F-fluorocholine, prevent any conclusions from being drawn concerning any possible diagnostic benefit of 18F-fluorocholine-based PET.
Clinical Benefit
| Substantial |
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Clinical Added Value
| no clinical added value |
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