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ZYTIGA (abiraterone acetate), androgen synthesis inhibitor

ONCOLOGY - New indication
Opinions on drugs - Posted on Aug 27 2018

Reason for request

Extension of indication

High clinical benefit for newly diagnosed high-risk hormone-sensitive metastatic prostate cancer and moderate clinical added value compared to androgen deprivation alone.

 

  • ZYTIGA has been granted a marketing authorisation, in combination with prednisone or prednisolone, for the treatment of newly diagnosed high-risk hormone-sensitive metastatic prostate cancer, for adults, in combination with androgen deprivation therapy (ADT).

  • A phase III study has demonstrated the superiority of the ZYTIGA + ADT + prednisone or prednisolone combination compared to ADT alone, in terms of overall survival. Exploratory analyses suggest a gain in quality of life compared to ADT alone.

  • It is not possible to determine its role compared to the docetaxel + ADT combination, due to the methodological limitations of the sole indirect comparison meta-analysis available.

 


Actual benefit

Important

-


Improvement in actual benefit

III (modéré)

la Commission considère que ZYTIGA en association à la suppression androgénique (ADT) apporte une ASMR modérée (ASMR III) par rapport à l’ADT seul, chez les patients atteints de cancer de la prostate métastatique hormono-sensible à haut risque nouvellement diagnostiqué, en association avec la prednisone ou la prednisolone.


Ce produit a fait l'objet d'un avis d'efficience rendu par la Commission Evaluation Economique et Santé Publique le 10 juillet 2018.

See also