XALKORI (crizotinib), tyrosine kinase inhibitor
Reason for request
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.
Improvement in actual benefit