Reason for request
Extension of the indication.
-
Clinical Benefit
Low |
The actual benefit of AFINITOR, in combination with exemestane, is low in this extension of the indication in the Marketing Authorisation. |
Clinical Added Value
no clinical added value |
In the current state of the dossier, given the uncertainties regarding the benefit of exemestane and the low level of effect of the combination everolimus/exemestane the Committee considers that the addition of AFINITOR to exemestane, does not provide an improvement in actual benefit (IAB V, non existent) compared with standard hormone receptor-positive, HER2/neu negative advanced breast cancer treatments, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. |
English version
Contact Us
Évaluation des médicaments