Reason for request

Extension of indication

High clinical benefit and minor clinical added value compared to XALKORI as first line treatment of metastatic non-small cell lung cancer with ALK gene rearrangement.

 

 

 

  • ALECENSA has been granted marketing authorisation for the first-line treatment in monotherapy of adults suffering from advanced metastatic non-small cell lung cancer (NSCLC) with ALK rearrangement.

  • Its superiority over XALKORI(crizotinib) in terms of progression-free survival has been demonstrated, though it is impossible to draw any conclusions concerning overall survival due to the study methodology.

  • Its tolerance profile is comparable to crizotinib.

  • It is the preferred first-line treatment for this population.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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Therapeutic use

-

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