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XALKORI (crizotinib), tyrosine kinase inhibitor

ONCOLOGY - New indication
Opinions on drugs - Posted on Jul 18 2018

Reason for request

Extension of indication

For the treatment of non-small cell lung cancer with ROS1 rearrangement, low clinical benefit for first-line treatment, moderate benefit for second-line and subsequent treatments, and no proven clinical added value for the management of this cancer


  • XALKORI has been granted a marketing authorisation for adults with non-small cell lung cancer (NSCLC) carrying ROS1 rearrangement.

  • The clinical data are limited for this indication with a low level of evidence and relating to an intermediate endpoint.

  • There is no comparison to chemotherapy conventionally used in this context, or robust data on the prognostic value of the presence of ROS1.



Actual benefit




Improvement in actual benefit

V (absence)


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