ZYKADIA (ceritinib), tyrosine kinase inhibitor
ONCOLOGY - New indication
Opinions on drugs -
Posted on
Nov 14 2018
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 |
- |
Clinical Added Value
minor |
- |
Therapeutic use
- |
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