Reason for request

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

Minor clinical added value relative to placebo in the treatment of castration-resistant prostate cancer, with symptomatic bone metastases

 

  • XOFIGO has had Marketing Authorisation since 2013 as a monotherapy in the treatment of castration-resistant prostate cancer, with symptomatic bone metastases and no known visceral metastases.
  • The benefit of radium dichloride treatment was established relative to placebo in patients with castration-resistant prostate cancer with symptomatic bone metastases. No new optimal-level study is available since the previous assessment.
  • In the absence of data, its role in the chronological sequence compared with abiraterone acetate or enzalutamide in patients presenting only bone metastases is unclear.

 

 


Clinical Added Value

minor

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Therapeutic use

-

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