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.
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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.
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Its superiority over chemotherapy has been established: absolute gain in median overall survival of 2.9 months in favour of pembrolizumab.
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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 |
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Clinical Added Value
minor |
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Economic analysis
English version
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