KEYTRUDA (pembrolizumab), monoclonal antibody
ONCOLOGY - New indication
Opinions on drugs -
Posted on
Jul 19 2018
Reason for request
Extension d'indication
High clinical benefit for urothelial cancer and minor clinical added value compared to chemotherapy in terms of overall survival.
KEYTRUDA has been granted a marketing authorisation for the monotherapy treatment of adults with locally advanced or metastatic urothelial cancer having received prior platinum salt-based chemotherapy.
Its superiority over chemotherapy has been established: absolute gain in median overall survival of 2.9 months in favour of pembrolizumab.
It is the preferred therapeutic option over chemotherapy for second- and third-line treatments for these patients. However, KEYTRUDA increases the risk of death in the first two months of treatment compared to chemotherapy.
Clinical Benefit
Substantial |
- |
Clinical Added Value
minor |
- |
-
Economic analysis
English version
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