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
Moderate |
- |
Low |
Clinical Added Value
no clinical added value |
- |
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