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Opinions on drugs - Posted on May 21 2013

Reason for request

Inclusion in the extension of indication.


Actual benefit


The actual benefit of HERCEPTIN is substantial in the indication in the Marketing Authorisation.

Improvement in actual benefit

Commentaires sans chiffrage de l'ASMR

In the current state of the dossier and given the absence of an impact on overall
survival for this medicinal product, the inappropriate choice of chemotherapy used in the pivotal study, the concomitant administration of anthracycline with HERCEPTIN in this study which is not recommended, and therefore the lack of transferability of the data obtained, the Committee considers that the IAB of HERCEPTIN in this extension of the indication cannot be assessed.

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