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HEXVIX (hexyl aminolevulinate), diagnostic medicinal product

Opinions on drugs - Posted on Apr 25 2016

Reason for request

Re-assessment of the improvement in actual benefit

Minor improvement in the treatment compared with white light cystoscopy alone in the detection of malignant bladder tissue in patients with a history or strong suspicion – on the basis of a screening cystoscopy or a positive urinary cytology – of bladder cancer

  • HEXVIX has Marketing Authorisation in addition to standard white light cystoscopy to contribute to the diagnosis and treatment of bladder cancer in patients with known or strongly suspected bladder cancer.
  • The increase in sensitivity resulting from fluorescence cystoscopy with HEXVIX compared with white light cystoscopy is about 20%. The specificity is comparable in each of the groups (10 to 39% false positives).
  • The increase in terms of the first tumour recurrence after the use of HEXVIX is low (8 to 10%), and no improvement in overall survival has been demonstrated.


Actual benefit



Improvement in actual benefit

IV (mineur)


Therapeutic use


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