KEYTRUDA (pembrolizumab), anti-PD1 antibody
ONCOLOGY - New indication
Opinions on drugs -
Posted on
Aug 27 2018
Reason for request
Extension of indication
High clinical benefit and moderate clinical added value compared to platinum salt-based bitherapy as first-line treatment for metastatic non-small cell lung cancer
KEYTRUDA has been granted a marketing authorisation for the first-line monotherapy treatment of adults suffering from metastatic non-small cell lung cancer (NSCLC) with tumours expressing PDL1 at the threshold ≥ 50%, without EGFR or ALK tumour mutation.
As a monotherapy, its superiority has been demonstrated over platinum salt-based bitherapy in terms of progression-free survival in the patient population with a
PD-L1 tumour expression of ≥ 50%.
Its safety profile is superior to that of platinum salt-based chemotherapy.
It is a first-line treatment for this population.
Clinical Benefit
Substantial |
- |
Clinical Added Value
moderate |
- |
-
Economic analysis
English version
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