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.
Improvement in actual benefit
Évaluation des médicaments