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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