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 Benefit

Substantial

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Clinical Added Value

minor

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Therapeutic use

-

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