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XOFIGO (radium dichloride), radioisotope

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Opinions on drugs - Posted on Sep 14 2015

Reason for request

Inclusion

Minor improvement in the treatment of castration-resistant prostate cancer, with symptomatic bone metastases and no known visceral metastases.

 

  • XOFIGO has Marketing Authorisation in the treatment of castration-resistant prostate cancer, with symptomatic bone metastases and no known visceral metastases. 

  • Its efficacy was demonstrated versus placebo on overall survival (difference of +2.8 months) and time to occurrence of the first symptomatic skeletal event (difference of +5.1 months).

  • In the absence of comparative data, its role in the therapeutic strategy compared with ZYTIGA (abiraterone acetate) in mildly symptomatic patients presenting only bone metastases is unclear.

 

 

 


Clinical Benefit

Substantial

The actual benefit of XOFIGO in the indication of treatment of castration-resistant prostate cancer, with symptomatic bone metastases and no known visceral metastases is substantial.


Clinical Added Value

minor

XOFIGO provides a minor improvement in actual benefit (IAB IV) compared with a placebo in the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.


Therapeutic use

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