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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.



Clinical Benefit




Clinical Added Value

no clinical added value


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