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Opinions on drugs - Posted on Jul 15 2013

Reason for request

Extension of the indication.


Clinical Benefit


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.

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