HEXVIX (hexyl aminolevulinate), diagnostic medicinal product
ONCOLOGY - Focus
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.
Improvement in actual benefit
Évaluation des médicaments