XTANDI (enzalutamide), androgen receptor signalling pathway inhibitor
ONCOLOGY - New indication
Opinions on drugs - Posted on Jun 08 2016
Reason for request
Extension of inclusion
Minor improvement in asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer, without indication for chemotherapy
- XTANDI now has Marketing Authorisation in the treatment of metastatic castration-resistant prostate cancer in asymptomatic or mildly symptomatic patients (most intense pain score experienced during the previous 24 hours ≤ 3 on a scale from 0 to 10), after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.
- It improves radiological progression-free survival, overall survival and median time to initiation of cytotoxic chemotherapy.
- XTANDI offers a minor improvement, the same as that of ZYTIGA in the treatment of metastatic castration-resistant prostate cancer prior to treatment with docetaxel.
Clinical Added Value
Évaluation des médicaments
HAS opinions and decisions