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.
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.
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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