Reason for request

Extension of indication

High clinical benefit and minor clinical added value compared to chemotherapy combining a platinum salt and pemetrexed, followed by maintenance treatment with pemetrexed, as first line treatment of metastatic non-small cell lung cancer with ALK gene rearrangement

 

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

  • Its superiority has been demonstrated over platinum salt-based chemotherapy in terms of progression-free survival, though without demonstrated impact on overall survival. This chemotherapy, however, is no longer the current treatment standard.

  • Its safety profile is superior to that of chemotherapy.

  • It is a 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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