Reason for request

Renewal of inclusion and Re-assessment of the actual benefit and of the improvement in actual benefit

No clinical benefit demonstrated by comparison with comparators in the treatment of prostate cancer.

  • DISTILBENE has a Marketing Authorisation in the treatment of prostate cancer.
  • No new clinical study has been conducted by the company.
  • The ANSM has identified a risk of severe cardiovascular and thromboembolic effects, even taking preventive anticoagulant treatment. There are no evidences between DISTILBENE and hepatobiliary adverse effects.
  • There is a potential benefit in a limited number of very weak or very old patients (without cardiovascular contraindication) who can no longer be treated by chemotherapy and who still develop the prostate cancer despite of complete adrenergic blockade. The absence of clinical efficacy data and a poor safety profile show that this clinical benefit is low in the prostate cancer treatment.

 


Clinical Benefit

Low

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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