Download opinion
Add to my selection
Quote this publication Print

XALKORI (crizotinib), tyrosine kinase inhibitor

TRANSPARENCY COMMITTEE OPINION
Opinions on drugs - Posted on May 22 2017

Reason for request

Extension of indication

High clinical benefit for the treatment of ALK + non-small cell lung cancer and minor clinical added value compared to platinum salt-based chemotherapy

  •  XALKORI has been granted a marketing authorisation for the first-line treatment of adults with advanced ALK-positive non-small cell lung cancer (NSCLC).

  • A study has demonstrated a gain in progression-free survival but with no impact on overall survival with XALKORI compared to platinum salt-based chemotherapy.

  • It is difficult to transfer the findings of the study conducted to real-life conditions of use due to different treatment schedules between the two groups.

  • This is a first-line treatment for advanced ALK+ NSCLC.

 

 


Clinical Benefit
Substantial

-

Clinical Added Value
minor

Compte tenu de : 

  • la démonstration d’un gain en survie sans progression 
  • sans impact démontré sur la survie globale par rapport à une chimiothérapie à base de sels de platine, 
  • la difficulté de transposer les résultats de l’étude pivot aux conditions réelles d’utilisation (schémas de traitement différents entre les deux groupes de traitement, en faveur de XALKORI),

la Commission considère que XALKORI apporte une ASMR mineure (ASMR IV) dans le traitement de première ligne du CPNPC ALK+ au stade avancé.

Therapeutic use

-

Documents

English version

Contact Us

Évaluation des médicaments
All our publications