XOFIGO (radium), radioisotope
ONCOLOGY - Update
Opinions on drugs - Posted on Mar 29 2017
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
Évaluation des médicaments