Reason for request
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.